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Structured telephone support or telemonitoring programmes for patients with chronic heart failure

  1. Sally C Inglis1,*,
  2. Robyn A Clark2,
  3. Finlay A McAlister3,
  4. Jocasta Ball1,
  5. Christian Lewinter4,
  6. Damien Cullington4,
  7. Simon Stewart1,
  8. John GF Cleland4

Editorial Group: Cochrane Heart Group

Published Online: 4 AUG 2010

Assessed as up-to-date: 20 NOV 2008

DOI: 10.1002/14651858.CD007228.pub2


How to Cite

Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JGF. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database of Systematic Reviews 2010, Issue 8. Art. No.: CD007228. DOI: 10.1002/14651858.CD007228.pub2.

Author Information

  1. 1

    Baker IDI Heart and Diabetes Institute, Preventative Health, Melbourne, Australia

  2. 2

    Queensland University of Technology, School of Nursing and Midwifery, Queensland, Australia

  3. 3

    University of Alberta, Division of General Internal Medicine, Edmonton, Canada

  4. 4

    Castle Hill Hospital, Academic Unit of Cardiology, East Yorkshire, UK

*Sally C Inglis, Preventative Health, Baker IDI Heart and Diabetes Institute, Melbourne, Australia. sally.inglis@uts.edu.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 4 AUG 2010

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This is not the most recent version of the article. View current version (31 OCT 2015)

 
Characteristics of included studies [ordered by study ID]
Angermann 2007

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants708 patients hospitalised for symptomatic systolic CHF with LVEF ≤ 40%.

Mean age 68 years.

71% of participants were male.

Germany.


InterventionsStructured telephone support.

Patients randomised to the disease management arm received telephone-based monitoring and modular education delivered by trained nurses that included educational material/self-monitoring schemes and multidisciplinary advice. These patients were required to attend six monthly visits to a CHF clinic.

Usual care consisted of care provided by the patients GP plus six monthly visits to a CHF clinic.


OutcomesAll cause mortality, time-to-first-event (all-cause death and hospitalisation), days alive and out of hospital, NYHA class, quality of life.

Six month follow-up.


NotesAbstract.

Final data still to be published. Contacted author no further outcome data offered until publication but methodology of trial and type of intervention confirmed with authors. The extracted data is from a published abstract.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskUnable to assess. Abstract only.

Allocation concealment (selection bias)Unclear riskUnable to assess. Abstract only.

Blinding (performance bias and detection bias)
Intervention
Unclear riskUnable to assess. Abstract only.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnable to assess. Abstract only.

Selective reporting (reporting bias)Unclear riskUnable to assess. Abstract only.

Was the study powered to detect differences in outcomes.Unclear riskUnable to assess. Abstract only.

Were the study groups comparable at baseline?Unclear riskUnable to assess. Abstract only.

Was the study reported according to CONSORT guidelines?Unclear riskUnable to assess. Abstract only.

Was the diagnosis of heart failure defined and appropriate?Unclear riskUnable to assess. Abstract only.

Antonicelli 2008

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


ParticipantsTelemonitoring.

57 patients hospitalised for worsening symptoms and signs of CHF with NYHA class II-IV, evidence of pulmonary congestions on chest x-ray and EF < 40%. Patients with NYHA class II-III with an EF > 40% and diastolic LV dysfunction were also included.

Mean age 78 years.

61% of participants were male.

Italy


InterventionsPatients randomised to home telemonitoring-based care were contacted by telephone at least once a week to collect information on symptoms and treatment adherence as well as BP, HR, weight and 24h urine output on the previous day. A weekly ECG transmission was also obtained. Patients were then evaluated and their regimen altered when necessary based on this data. Additionally, clinic visits were performed when required based on the data collected or telephone interviews.

Usual care involved receiving stand care based on routinely scheduled clinic visits (every four months) performed by a team specialized in CHF patient management. These subjects were also contacted monthly by telephone to collect data on new hospital admissions, complications and death. Additional clinic visits were performed whenever required when clinical status altered.


OutcomesCombined rate of mortality and hospitalisation, these rates considered individually, quality of life.

12 month follow-up.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not stated.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo evidence of incomplete outcome data.

Selective reporting (reporting bias)Low riskNo evidence of selective outcome reporting.

Was the study powered to detect differences in outcomes.Low riskPower calculation performed for sample size for primary outcome - combined rate of mortality and hospitalisation. Study powered for this outcome.

Were the study groups comparable at baseline?High riskSeveral variables were different between the control and intervention groups at baseline.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskDiagnosis of heart failure based on presence of CHF signs and symptoms, pulmonary congestion on chest x-ray, and ejection fraction on echocardiogram.

Balk 2008

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants214 patients with CHF and NYHA class I-IV.

Mean age 66 years.

70% of participants were male.

The Netherlands.


InterventionsTelemonitoring.

Patients in the Intervention group were provided a MOTIVA system (TV-channel providing educational material, reminders of medication, health related surveys and motivational messages to encourage the prescribed lifestyle regimen) in addition to scheduled cardiologist appointments. A subgroup of intervention patients also received automated BP and weight devices that automatically communicated readings via the telephone (those who had been hospitalised in the prior year for HF). Patient guidance followed a personalised plan.

Control subjects were followed by their cardiologists and HF-nurses according to standard local practice.

All patients recorded all contacts with health care professionals and hospital admissions.


OutcomesAll-cause hospital days per year, days alive and out of hospital, quality of life, knowledge of disease, self-care.

288 days - mean follow-up.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomisation was performed in a 1:1 ratio, in randomly permuted blocks of 30 per participating centre. Randomisation was independently performed...via a special Web-based application" p1138.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Appears that an independent organization that performed the randomisation also analysed the data.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo evidence of incomplete outcome data.

Selective reporting (reporting bias)Low riskNo evidence of selective outcome reporting.

Was the study powered to detect differences in outcomes.Unclear riskNo power analysis for sample size - authors state that "...a meaningful power analysis was not possible because of absence of data in the literature and insufficient data from hospitals on hospital admissions for these patients, who had not necessarily had a recent admission to hospital for heart failure treatment..." p1138.

Were the study groups comparable at baseline?High riskSome slight differences were observed between the two groups at baseline.

Was the study reported according to CONSORT guidelines?Unclear riskNot reported using CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskSpecific clinical criteria to confirm heart failure diagnosis not detailed. Patients with chronic heart failure in NYHA class I–IV and under the care of cardiologists were eligible.

Barth 2001

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants34 patients discharged from acute care to home with primary diagnosis of CHF.

Mean age 75 years.

47% of participants were male.

USA


InterventionsStructured telephone support.

Structured nurse-managed telephonic post-discharge program involving pre-discharge education plus post discharge telephone follow-up. Structured interaction at 72 hours, 144 hours, and then fortnightly.

The control group received routine discharge teaching at the time of discharge as per hospital procedure. Patients were contacted at two months for collection of data.


OutcomesMortality, rehospitalisation, physician and emergency department visits, quality of life, cost of the intervention.

Three months follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not stated.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)Unclear riskUnable to assess, not detailed.

Was the study powered to detect differences in outcomes.Unclear riskNot detailed.

Were the study groups comparable at baseline?Low riskNo significant differences observed in baseline characteristics between the two groups.

Was the study reported according to CONSORT guidelines?High riskStudy was not reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Blum 2007 (MCCD)

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants204 subjects with heart failure.

Mean age 72 years.

71% of participants were male.

USA


InterventionsTelemonitoring.

All subjects were given written material about heart failure and self-management activities such as daily weights, medication administration, signs and symptoms of worsening heart failure and were given an opportunity to ask questions or seek clarification as the handout was discussed.  

The usual care group was not contacted again until time to schedule the six-month follow-up appointment.

Intervention subjects were instructed to use the scale, blood pressure cuff/heart rate monitor and the heart rhythm strip monitor at the same time each day. The transmitted data was then compared to individually assigned parameters based on the subject's admission and subsequent evaluations.  Readings outside these parameters were flagged for the nurse practitioner (NP) who did the monitoring. This NP, who had extensive experience in the management of heart failure patients contacted the subject to gather more information and, if appropriate, adjusted medications, usually diuretics.  There were no specific protocols as to the management decisions and decisions were based on the NP's experience and/or consultation with the subject's cardiologist. If no flags were noted over the period of one month, the subjects were called just to maintain contact, provide encouragement and answer any questions they might have.  Subjects were encouraged to call the NP any time they wished and they were given the phone number of the direct line to the NP's office.  Reports of weight and vital sign trends were sent to participating cardiologists' office prior to office visits. Monitoring was performed seven days a week.


OutcomesAll-cause mortality, hospitalisations (as provided by the authors). Quality of life using SF-36 and Minnesota Living with Heart Failure Questionnaire (presented in abstract). BNP (outcomes not included in review as only mortality and hospitalisation data provided)

12 month follow-up.


NotesAbstract and author communication.

Meta-analysis performed using number of patients randomised (n = 204). 


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The subject's identification information was entered into the Mathematica Policy Research (MPR) randomisation website and the designation of participant (telemonitored group) or control (usual care) was returned" author correspondence.

Allocation concealment (selection bias)Low riskRandomization performed after informed consent given by participant.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"Two subjects declined to continue after signing consent and only partial or no data were collected on them, one in the usual care group and one in the monitored group.  Therefore, complete baseline data was collected on 202 subjects.  One subject completed all of the first visit data and then declined to accept the monitoring equipment when it was delivered.  These subjects were eliminated from the data analysis leaving 201 subjects; 100 in the usual care group and 101 in the monitored group" author correspondence.

Selective reporting (reporting bias)Unclear riskUnable to assess. Abstract only.

Was the study powered to detect differences in outcomes.Unclear riskUnable to assess. Abstract only.

Were the study groups comparable at baseline?Unclear riskUnable to assess. Abstract only.

Was the study reported according to CONSORT guidelines?Unclear riskUnable to assess. Abstract only.

Was the diagnosis of heart failure defined and appropriate?Unclear riskUnable to assess. Abstract only.

Capomolla 2004

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants133 patients discharged from specialist CHF unit to home.

Mean age 57 years.

88% of participants were male.

Italy


InterventionsTelemonitoring.

Daily communication of vital signs (including weight, systolic BP, HR) and symptoms with review by nurses and physicians. Access to medical staff via phone as needed was available.

Usual care consisted of a referral to the patients primary care physician or cardiology department at discharge. Post-discharge care was governed by the care provider.


OutcomesMortality, re hospitalisation, emergency department visits, compliance with intervention.

12 month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not stated.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)Low riskNo evidence of selective outcome reporting.

Was the study powered to detect differences in outcomes.Unclear riskSample size calculation not detailed.

Were the study groups comparable at baseline?Low riskNo significant differences in baseline variables evident.

Was the study reported according to CONSORT guidelines?High riskStudy not reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Cleland 2005 (Telemon)

MethodsRandomised controlled trial; multiple intervention arms and control (usual care) arm.


Participants426 patients with a recent admission for heart failure and LVEF < 40%.

Mean age 67 years.

77% of participants were male.

Germany, Netherlands, UK


InterventionsStructured telephone support; telemonitoring.

Patients assigned to the nurse telephone support arm received a telephone call each month by a heart failure specialist nurse to assess their symptoms and current medications.

Patients assigned to telemonitoring received the nurse telephone support and had their weight, BP and ECG monitored twice daily.

Usual care consisted of a management plan forwarded to the patient’s primary care physician, who was asked to implement it. If the practice involved nurse titration of drugs this was allowed. Patients were assessed at a research clinic every four months; contact with the clinic was discouraged between clinic visits.


OutcomesMortality, rehospitalisation, compliance with intervention.

240 day and 450 day follow-up.


NotesThree armed study with both telephone and telemonitoring.

Included in previous systematic review and meta-analysis Clark 2007a.

Results included in meta-analysis are from 240 day follow-up.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom permuted blocks - correspondence from author.

Allocation concealment (selection bias)Low riskAfter consent and collection of baseline data an independent statistical centre was contacted - correspondence from author.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot stated.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"...Four were lost to follow-up and 12 declined to comply with regular telemonitoring" p1659. "

"Analyses were conducted by intention-to-treat" p1659.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.Low riskPower calculation performed. Study powered for the primary outcome days lost because of death or hospitalisation in acute medical/surgical beds for any reason during 450 days, after an interim analysis
the duration of follow-up was reduced to 240 days.

Were the study groups comparable at baseline?Unclear riskThe study groups appear to be similar at baseline.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according the CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskUnable to assess.

Cleland 2005(Struct Tele)

MethodsRandomised controlled trial; multiple intervention arms and control (usual care) arm.


Participants426 patients with a recent admission for heart failure and LVEF < 40%.

Mean age 67 years.

77% of participants were male.

Germany, Netherlands, UK


InterventionsStructured telephone support; telemonitoring.

Patients assigned to the nurse telephone support arm received a telephone call each month by a heart failure specialist nurse to assess their symptoms and current medications.

Patients assigned to telemonitoring received the nurse telephone support and had their weight, BP and ECG monitored twice daily.

Usual care consisted of a management plan forwarded to the patient’s primary care physician, who was asked to implement it. If the practice involved nurse titration of drugs this was allowed. Patients were assessed at a research clinic every four months; contact with the clinic was discouraged between clinic visits.


OutcomesMortality, rehospitalisation, compliance with intervention.

240 day and 450 day follow-up.


NotesThree armed study with both telephone and telemonitoring.

Included in previous systematic review and meta-analysis Clark 2007a.

Results included in meta-analysis are from 240 day follow-up.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom permuted blocks - correspondence from author.

Allocation concealment (selection bias)Low riskAfter consent and collection of baseline data an independent statistical centre was contacted - correspondence from author.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot stated.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"...Four were lost to follow-up and 12 declined to comply with regular telemonitoring" p1659. "

"Analyses were conducted by intention-to-treat" p1659.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.Low riskPower calculation performed. Study powered for the primary outcome days lost because of death or hospitalisation in acute medical/surgical beds for any reason during 450 days, after an interim analysis
the duration of follow-up was reduced to 240 days.

Were the study groups comparable at baseline?Unclear riskThe study groups appear to be similar at baseline.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according the CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskUnable to assess.

de Lusignan 2001

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants20 patients with heart failure confirmed by cardiologist, identified from the database of an academic general practice.

Mean age 75 years.

Number or proportion of males and females not specified.

UK.


InterventionsTelemonitoring.

Telemonitoring of vital signs (pulse, BP, weight) and clinical status daily assessed daily by nurses along with video consults with a nurse weekly for three months, fortnightly for three months, then monthly.

Usual care consisted of standard general practice treatment; in addition they had their pulse, BP and weight measured quarterly. They were evaluated in the same manner as the intervention group. 


OutcomesMortality, compliance with intervention and medication, patient satisfaction, quality of life.

12 month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The first 20 patients identified by random table allocation 10 to the telemedicine and 10 to the control group..." p724.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)Low riskNo evidence of selective outcome reporting.

Was the study powered to detect differences in outcomes.Unclear riskSample size calculation not detailed.

Were the study groups comparable at baseline?Unclear riskNot detailed.

Was the study reported according to CONSORT guidelines?High riskStudy not reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

DeBusk 2004

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants462 patients hospitalised with a provisional diagnosis of CHF from Kaiser Permanente.

Mean age 72 years.

51% of participants were male.

USA.


InterventionsStructured telephone support.

Standardised telephonic physician directed nurse-managed case management, involving CHF lifestyle education and medication management. Patients contacted weekly for 6 weeks, biweekly for 8 weeks and then monthly and bimonthly.

Usual care not clearly defined, but was provided by the participating Kaiser Permanente medical centres,  appeared to involve a high frequency of all of kinds of follow-up clinic visits (13 in 12 months following hospitalisation).


OutcomesMortality, rehospitalisation, emergency and outpatient department visits, prescription of recommended pharmacotherapy.

12 months follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Equal numbers of patients were allocated to the 2 groups in each medical center by using the Efron procedure". p607.

Allocation concealment (selection bias)Low risk"Research staff who were not associated with delivering the intervention randomly assigned patients to treatment conditions by using sealed assignments." p607

Blinding (performance bias and detection bias)
Intervention
Low risk"Research staff who were not associated with, and were blinded to, the intervention conditions measured health outcomes at 12 months" p608.

"Two cardiologists who were not associated with implementing the intervention reviewed medical records on deaths, rehospitalisation, and emergency department visits to determine whether these events were primarily due to heart failure or due to other causes". p608.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"During the first year of follow-up, 23 patients (3%) dropped out of the trial (8 in the treatment group and 15 in the usual care group)" p608.

The analysis was by intention-to-treat.

Selective reporting (reporting bias)Low riskNo evidence of selective reporting.

Was the study powered to detect differences in outcomes.Low riskPower calculation performed. Study powered for risk for rehospitalization for heart failure.

Were the study groups comparable at baseline?Low riskNo statistically significant differences in the two groups at baseline.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskBased on signs and symptoms of heart failure: shortness of breath (dyspnoea at
rest, including orthopnoea or paroxysmal nocturnal dyspnoea) and at least 1 corroborating clinical sign (pulmonary congestion on examination, including rales, crackles, or wheezes) or radiologic abnormality (pulmonary congestion on chest radiograph) consistent with heart failure.

DeWalt 2006

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants127 patients with confirmed HF, NYHA class II-IV symptoms within the last 3 months and currently taking furosemide from the University of North Carolina (UNC) General Internal Medicine Practice.

Mean age 62.5 years.

47% of participants were male.

USA.


InterventionsStructured telephone support.

Intervention patients received self-care education, picture-based educational materials with verbal explanation, a digital scale and scheduled follow-up phone calls (days 3, 7, 14, 21, 28, 56) and monthly during months 3-6 for reinforcement of education and revision of individualised care plan.

Control group patients received a general heart failure education pamphlet and usual care from their primary physician (not specified). Data collection occurred at 6 and 12 months via in-person interview and medical record review.


OutcomesMortality, all-cause re-hospitalisation, HF-related quality of life, HF self-efficacy, HF knowledge, reported weight monitoring (self-management behaviour).

12 month follow-up.


NotesMeta-analysis performed using number of patients randomised (n = 127)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"..randomised patients by concealed allocation based on a random number generator" p2.

Allocation concealment (selection bias)Unclear riskUnclear if randomisation performed before or after consent provided.

Blinding (performance bias and detection bias)
Intervention
High risk"Research assistant was not blinded to patients study group” p3.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"Patients who did not return any phone calls and did not return for follow-up assessment did not have outcome data for analysis. Patients who withdrew from the study were censored at the time of withdrawal; any data collected prior to withdrawal were included in the analysis" p5.

"Of those randomised to the control group, 1 never returned after the first visit, 1 withdrew during the study and 4 died during the study. Follow-up was completed for all of the remaining participants (98%)" p5.

Selective reporting (reporting bias)Low riskNo evidence of selective reporting.

Was the study powered to detect differences in outcomes.Unclear riskPower calculation for sample size to detect differences in heart failure-related quality of life. Study not powered to detect differences in hospitalizations.

Were the study groups comparable at baseline?High riskAt baseline, most characteristics were similar between the two groups.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low risk"Patients had to have a clinical diagnosis of heart failure confirmed by their primary provider through
a direct interview, and one of the following: 1) chest x-ray findings consistent with heart failure, 2) ejection fraction <40% by any method, or 3) a history of peripheral edema. They also had to have New York Heart Association class III-V symptoms within the last 3 months" p2.

Galbreath 2004

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants1069 patients with symptoms of CHF and documented systolic (mean EF 35%) or diastolic dysfunction (echo confirmed).

Mean age 71 years.

71% of participants were male.

USA.


InterventionsStructured telephone support.

All intervention patients received bathroom scales and were designated a disease manager who administered the disease management program telephonically. Initial call frequency was weekly then transitioned to monthly for the duration of the study. Call frequency could be adjusted for acuity or need. After each call a call summary was faxed to the patients primary care provider.

An additional randomisation was performed within the intervention arm, with some participants provided with in-home technology (BP monitor, pulse oximeter) - these measurements were reported by the patient to the disease manager, but the data were not forwarded to the primary care provider. These patients also wore activity monitors at regular intervals and had six-monthly measurement of thoracic bioimpedance cardiac output - these data were not forwarded to the primary care physician.

The authors state: "because data derived from the technology were not used in clinical management, we combined results from the two treatment groups for the purposes of this analysis."

Traditional care patients were managed as usual by their physicians.


OutcomesAll-cause mortality, six-minute walk performance, functional therapeutic class improvement, total healthcare costs. Improvement in ejection fraction improvement and medication adherence were assessed in a subgroup.

18 month follow-up.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Participants were randomised in a 2:1 ratio between the treatment and control groups" p3519.

Method of randomisation not detailed.

Allocation concealment (selection bias)Low riskRandomisation performed after informed consent obtained.

Blinding (performance bias and detection bias)
Intervention
High risk"Reviews were performed by study staff, consisting of physicians, nurses, and ancillary health providers" p3519.

Incomplete outcome data (attrition bias)
All outcomes
High riskSome evidence of attrition of study participants but actual numbers not presented.

Selective reporting (reporting bias)Low riskNo evidence of selective reporting.

Was the study powered to detect differences in outcomes.Low riskSample size calculation performed; study powered for primary and secondary outcomes.

Were the study groups comparable at baseline?Unclear riskDiastolic blood pressure for patients with systolic heart failure the only baseline variable that was statistically significant between the groups.

Was the study reported according to CONSORT guidelines?High riskStudy not reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskBased on echocardiographic findings.

Gattis 1999 (PHARM)

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants181 patients with heart failure being evaluated in cardiology clinic.

Mean age 67 years.

68% of participants were male.

USA.


InterventionsStructured telephone support.

Clinical pharmacist-led medication review and patient education. Regularly scheduled telephone contact (at two, 12 and 24 weeks) to detect clinical deterioration early.

The control group received usual care which did not include the pharmacist providing recommendations regarding drug therapy to the attending physician or providing education to the patient. Patient assessment and education were provided by the attending physician and/or physician assistant or nurse practitioner. The patient was contacted by the pharmacist via telephone to identify clinical events.


OutcomesMortality, rehospitalisation, medication prescription.

Six month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"...patients were randomised according to a computer-generated randomisation scheme.." p1940.

Allocation concealment (selection bias)High riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Low risk"Clinical events and current drug therapy were documented on follow-up data collection forms during telephone follow-up or return visits" p1941.

"..clinical events were adjudicated by a blinded physician clinical events committee using standard adjudication forms" p1941.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)Low riskNo evidence of selective reporting.

Was the study powered to detect differences in outcomes.Unclear riskPower calculation not detailed.

Were the study groups comparable at baseline?High riskBaseline characteristics were similar between the groups, with the median age of patients in the intervention group slightly higher.

Was the study reported according to CONSORT guidelines?High riskStudy not reported according to CONSORT guidelines (losses to follow-up not detailed).

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

GESICA 2005 (DIAL)

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants1518 outpatients with stable CHF. 

Mean age 65 years.

71% of participants were male.

Argentina.


InterventionsStructured telephone support.

Nurses trained in the management of patients with CHF performed structured telephone follow-up involving based on adherence to diet and treatment, monitoring of symptoms, control of fluid retention and daily physical activity.  Patients were contacted four times in the first fortnight and then as needed.

Patients in the control group were followed by their attending cardiologists and received care similar to the intervention group


OutcomesMortality, rehospitalisation, quality of life.

Mean 16 month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"We then used concealed randomisation lists to do permuted block randomisation stratified by attending cardiologist " p2.

Allocation concealment (selection bias)Low riskAfter provision of consent, patient's cardiologist contacted study centre (BMJ comment).

Blinding (performance bias and detection bias)
Intervention
Low risk"The clinical events committee, which was blinded to the patients' treatment group assignment, adjudicated all outcomes" p2.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"Follow-up was completed in 1511 (99.5%) randomised patients" p2.

"We based all analyses on the intention to treat principle" p2.

Selective reporting (reporting bias)Low riskNo evidence of selective reporting.

Was the study powered to detect differences in outcomes.Unclear riskPower calculation performed. Study was powered for the primary endpoint - all cause mortality or admission to hospital for worsening heart failure.

Were the study groups comparable at baseline?Low riskThe baseline variables were similar between the two groups.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Giordano 2009

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants460 confirmed CHF patients with LVEF < 40% and at least one hospitalisation for acute HF in the prior year.

Mean age 57 years.

85% of participants were male.

Italy.


InterventionsTelemonitoring.

Home-Based Telemanagement (HBT) patients received a one-lead trace portable device that transferred results via telephone where a nurse was available for interactive teleconsultation. Scheduled standardised telemonitoring appointments were performed every week to15 days depending on HF severity discussing symtomology, medications, self-care and, if required, the transmission of the ECG trace.

Usual care consisted of patients being referred to their primary care physician (PCP) and cardiologist for clinical management. These patients attended a two-weeks post-discharge PCP appointment and a structured follow-up outpatient cardiologist appointment at 12 months.


OutcomesUnplanned cardiovascular hospital readmissions, hospitalisation for HF, haemodynamic instability episode occurrence, cardiovascular mortality.

12 month follow-up.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Random permuted blocks for each center were used to allocate patients to treatment groups" p193.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"...one patient in UC group and four in HBT group were lost to follow-up" p196.

"Analyses were conducted according to the intention-to treat approach" p195.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.Low riskSample size calculation performed for primary outcome - one-year readmission rate. Study was adequately powered.

Were the study groups comparable at baseline?High risk"The randomisation groups differed significantly only with regard to use of digitalis and beta-blockers, which was respectively higher and lower in the UC group" p196.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low risk"...left ventricular ejection fraction (LVEF) < 40% and at least one hospitalisation for acute HF in the previous year" p193.

Goldberg 2003 (WHARF)

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants280 patients hospitalised with NYHA Class III-IV, with a LVEF < 35%.

Mean age 59 years.

68% of participants were male.

USA.


InterventionsTelemonitoring.

Daily transmission of weight and symptoms using a customised monitor, data was reviewed daily by nurses and concerns reported to the physician.

Patients in the control group were instructed to contact their physician for weight increases of more than a pre-specified amount or if their symptoms of heart failure worsened. They had a weight log to bring to visits. Follow-up visits, other than study visits were at the discretion of the treating physician. Telephone contacts were permitted at the discretion of the treating physician or nurse.


OutcomesMortality, rehospitalisation, emergency department visits, quality of life, patient satisfaction, compliance with intervention.

Mean six month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not detailed.

Allocation concealment (selection bias)Low riskRandomised performed after informed consent obtained.

Blinding (performance bias and detection bias)
Intervention
Low risk"To insure that all hospitalizations, emergency room visits, and deaths were identified, all patients were contacted by telephone on a monthly basis by a non medical surveyor (blinded to patient treatment group randomisation), located outside of the enrolment sites and Alere monitoring centre” p707.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"During the study, 32 patients either refused follow-up data collection or were lost to follow-up. Seven patients received cardiac transplantation and were censored on the day of transplant. Excluding deaths, there was no difference between groups in the percentage of patients who failed to complete six months of follow-up" p707.

Selective reporting (reporting bias)Unclear riskSome nominated outcomes (satisfaction) were not reported.

Was the study powered to detect differences in outcomes.High riskSample size calculation not reported.

Were the study groups comparable at baseline?Low riskGroups were comparable at baseline.

Was the study reported according to CONSORT guidelines?High riskStudy not reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low risk"...a left ventricular ejection fraction, measured within 6 months of enrolment, of ≤ 35%" p706.

Kielblock 2007

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants502 participants discharged after a hospitalisation with heart failure or with a confirmed diagnosis from ICD codes from hospital insurance data.

Mean age 74 years.

51% of participants were male.

Germany.


InterventionsTelemonitoring.

The intervention group all received a set of electronic scales which were attached to the monitoring centre via modem and regular CHF information and education via phone. Daily weight was monitored and responded to by CHF specialist team members. 72 patients also had BP monitored by this method. Control group participants received CHF education from GP.

The first 50 patients in the intervention group were visited at home by the health coach at the start of the study in order to set-up the telemetric equipment and to assess their ability to use the devices.

Patients were contacted whenever their body weight exceeded a threshold value, were phoned by a designated personal adviser and received regular informative material and advice by specialist medical personnel. Patients' general practitioners sent them follow-up reports.

Control group described as patients who had not received the described telemetric intervention.


OutcomesMortality, hospital stay duration, hospital and drug costs, total costs per patient.

12 month follow-up.


NotesTranslated from German. Authors provided details in English and additional data.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk"Participants were randomised on the basis of date of birth to either the control group (date of birth 21st-31st of the month; n = 251) or assigned as candidates to the management programme (date of birth 1st-20th of the month; n = 746)" from details of the study provided by the study authors.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)Unclear riskUnable to assess. Not detailed.

Was the study powered to detect differences in outcomes.Unclear riskNot detailed.

Were the study groups comparable at baseline?High riskSlightly older (Intervention 71 years vs Control 76 years) and more females (Intervention 42.6% vs Control 55.3%)

Was the study reported according to CONSORT guidelines?High riskNo CONSORT Study Flow chart presented

Was the diagnosis of heart failure defined and appropriate?Unclear riskYes "patienten mit den relevant ICD-Diagnosen (150.1, 150.11-19 150.9) zur chronisch Herzinsuffizienz wurden Datenbestand der KKH p 418

Krum 2009 (CHAT)

MethodsCluster randomised controlled trial. Computer generated random sequence.

GP practices were the unit of randomisation. GPs were not blinded to allocation group before recruiting and consenting patients.


Participants405 patients with a recent hospital discharge due to a primary diagnosis of heart failure with an EF of 40% and in NYHA class II–IV were randomised to either usual care or usual care plus telephone monitoring performed at least once per month.

Mean age - not reported.

% Men - not reported.

Australia.


InterventionsStructured telephone support

Nurse-led telephone monitoring using the Telewatch System (Baltimore).

Patient responded to computer generated CHF self-monitoring questions by pressing the numbers on the touch phone key pad.

Nurse survey in-coming calls daily and responded to pre-set variations to patients parameters.

Usual care discharge follow-up with GP and copy of guidelines.


OutcomesThe primary endpoint was the change in Packer clinical composite score. HRQOL, BNP.

Patients were assessed by a blinded reviewer at baseline and then after 6 and 12 months.

12 months follow-up.


NotesFinal results not published.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskUnable to assess. Abstract only.

Allocation concealment (selection bias)Unclear riskUnable to assess. Abstract only.

Blinding (performance bias and detection bias)
Intervention
Unclear riskUnable to assess. Abstract only.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnable to assess. Abstract only.

Selective reporting (reporting bias)Unclear riskUnable to assess. Abstract only.

Was the study powered to detect differences in outcomes.Unclear riskUnable to assess. Abstract only.

Were the study groups comparable at baseline?Unclear riskUnable to assess. Abstract only.

Was the study reported according to CONSORT guidelines?Unclear riskUnable to assess. Abstract only.

Was the diagnosis of heart failure defined and appropriate?Low riskUnable to assess. Abstract only.

Laramee 2003

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants287 patients admitted to hospital with primary or secondary diagnosis of CHF LVSD < 40% or radiological evidence of pulmonary oedema.

Mean age 71 years.

54% of participants were male.

USA.


InterventionsStructured telephone support.

Telephonic case management performed by one CHF nurse case manager, involving four major components: early discharge planning, patient and family CHF education, promotion of optimal CHF medications and 12 weeks of telephone follow-up. 

Usual care consisted of standard care typical of a tertiary care hospital. It included inpatient social service evaluation (25%), dietary consultation (15%), physiotherapy/occupational therapy (17%) and medication and CHF education by nurses. Post-discharge was conducted by the patient's own local physician, 44% received some home care services. 


OutcomesMortality, rehospitalisation, inpatient and outpatient costs, medication prescription and adherence.

Three month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"After simple randomisation of the first 42 patients resulted in large amounts of patients being assigned to one group or the other, patients were randomised in blocks of 8 to endure an even group allocation across time" p810.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk“Patients who withdrew, died or were otherwise lost before 90 days of follow-up were censored on the day of early attrition”.

Selective reporting (reporting bias)High riskOne secondary outcome not reported - number of days until first readmission.

Was the study powered to detect differences in outcomes.High riskPower calculation not detailed.

Were the study groups comparable at baseline?High riskSome variables differed between the study groups.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskClinical signs and symptoms and either evidence of moderate-to-severe left ventricular dysfunction or radiographic evidence of pulmonary congestion and symptomatic improvement following diuresis.

Mortara 2009 (Struct Tele)

MethodsRandomised controlled trial; multiple intervention arms and control (usual care) arm.


Participants461 heart failure patients with NYHA class II-IV and LVEF ≤ 40%.

Mean age 60 years.

85% of participants were male.

UK, Poland, Italy


InterventionsStructured telephone support; telemonitoring.

Patients allocated to home telemonitoring were further randomised into 3 groups.

The first group (strategy 1) received monthly supportive telephone contacts from a study nurse to check on their clinical status.

The second group (strategy 2) received the same telephone support, but also transmitted their vital signs and other data including details of changes in weight, BP and symptoms weekly by telephone. These patients also performed monthly 24h cardiorespiratory recordings which were not made available to the clinical team.

The third group (strategy 3) carried out the same measurements as strategy 2 patients, but the monthly 24h cardiorespiratory recordings were made available for clinical management.

Usual care was only described as usual outpatient care.


OutcomesMortality and hospitalisation due to HF, all-cause mortality, all-cause hospitalisation, bed-days occupancy (due to cardiovascular cause).

Mean 11.6 month follow-up.


NotesStrategies 2 and 3 combined and classed as telemonitoring.

Authors provided additional unpublished data.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"The randomisation list was generated by the coordinating centre with separate blocks held in each country" p313.

Allocation concealment (selection bias)Low risk"The individual patient allocation was to be revealed only after the patient identifiers (name, surname and the date of birth) had been received at the national randomisation centre" p313.

Blinding (performance bias and detection bias)
Intervention
Low risk"All endpoints were adjudicated by an independent, blinded, Endpoint Committee" p314.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"...18 patients dropped out of the study..." p315.

No statement asserting that analyses were performed as intention-to-treat.

Selective reporting (reporting bias)Unclear riskAll-cause mortality listed as a secondary outcome but not reported in publication according to study group. Author contacted for this information.

Bed days occupancy for all cardiovascular causes listed as secondary outcome. Not reported, unless "all-causes" is actually all "cardiovascular causes".

Was the study powered to detect differences in outcomes.Low riskPower calculation performed, study powered for both primary endpoints - bed-days occupancy for HF in
acute medical/surgical beds and composite endpoint of cardiac death and hospitalisation due to HF.

Were the study groups comparable at baseline?High riskSome variables differed between the study groups.

Was the study reported according to CONSORT guidelines?Low riskReported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskBased on NYHA class and echocardiographic findings.

Mortara 2009 (Telemon)

MethodsRandomised controlled trial; multiple intervention arms and control (usual care) arm.


Participants461 heart failure patients with NYHA class II-IV and LVEF ≤ 40%.

Mean age 60 years.

85% of participants were male.

UK, Poland, Italy


InterventionsStructured telephone support; telemonitoring.

Patients allocated to home telemonitoring were further randomised into 3 groups.

The first group (strategy 1) received monthly supportive telephone contacts from a study nurse to check on their clinical status.

The second group (strategy 2) received the same telephone support, but also transmitted their vital signs and other data including details of changes in weight, BP and symptoms weekly by telephone. These patients also performed monthly 24h cardiorespiratory recordings which were not made available to the clinical team.

The third group (strategy 3) carried out the same measurements as strategy 2 patients, but the monthly 24h cardiorespiratory recordings were made available for clinical management.

Usual care was only described as usual outpatient care.


OutcomesMortality and hospitalisation due to HF, all-cause mortality, all-cause hospitalisation, bed-days occupancy (due to cardiovascular cause).

Mean 11.6 month follow-up.


NotesStrategies 2 and 3 combined and classed as telemonitoring.

Authors provided additional unpublished data.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"The randomisation list was generated by the coordinating centre with separate blocks held in each country" p313.

Allocation concealment (selection bias)Low risk"The individual patient allocation was to be revealed only after the patient identifiers (name, surname and the date of birth) had been received at the national randomisation centre" p313.

Blinding (performance bias and detection bias)
Intervention
Low risk"All endpoints were adjudicated by an independent, blinded, Endpoint Committee" p314.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"...18 patients dropped out of the study..." p315.

No statement asserting that analyses were performed as intention-to-treat.

Selective reporting (reporting bias)Unclear riskAll-cause mortality listed as a secondary outcome but not reported in publication according to study group. Author contacted for this information.

Bed days occupancy for all cardiovascular causes listed as secondary outcome. Not reported, unless "all-causes" is actually all "cardiovascular causes".

Was the study powered to detect differences in outcomes.Low riskPower calculation performed, study powered for both primary endpoints - bed-days occupancy for HF in
acute medical/surgical beds and composite endpoint of cardiac death and hospitalization due to HF.

Were the study groups comparable at baseline?High riskSome variables differed between the study groups.

Was the study reported according to CONSORT guidelines?Low riskReported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskBased on NYHA class and echocardiographic findings.

Rainville 1999

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants38 patients aged ≥ 50 years discharged from hospital with heart failure.

Mean age 70 years.

50% of participants were male.

USA.


InterventionsStructured telephone support.

Usual care plus a pharmacist-led medication review, patient education, medication management prior to discharge and at Day 3, Day 7, 30 days, 90 days and 12 months via telephone.

Usual care consisted of routine care and preparation for discharge including written prescriptions, physician discharge instructions and a nurse review of diet, treatment plans and medications. The nurses provided the patient with computer generated drug information sheets. Patients were contacted by a pharmacist at 30 days, 90 days and 12 months to determine readmissions.


OutcomesMortality, rehospitalisation, functional assessment score. NYHA Functional Class.

12 month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.

Meta-analysis performed using number of patients randomised (n = 38).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not detailed.

Allocation concealment (selection bias)Low risk"Qualified patients were randomly assigned to a control group or an intervention group, with the patients, nurses, and physicians blinded to the randomisation results" p1339

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Low risk38 patients randomised; two patients in intervention group and one in control group were excluded during the initial hospitalisation because test results showed normal left ventricular function; long-term dialysis was initiated or because the patient was moving out of state after DC. One control patient was lost to follow-up within the first 30 days after discharge and was excluded from the analysis.

Final sample included 34 patients equally divided between the two groups.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.High riskPower calculation not detailed.

Were the study groups comparable at baseline?High riskSome variables differed between the groups.

Was the study reported according to CONSORT guidelines?High riskStudy not reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Ramachandran 2007

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants50 patients attending heart failure clinic with symptoms of CHF and LVEF < 40%.

Mean age 44.5 years.

78% of participants were male.

India.


InterventionsStructured telephone support.

Intervention group patients were managed in the heart failure clinic and received disease, medication and self-management education and telephonic disease management which consisted of reinforcement of information and drug dose modification.

The control group was managed as per usual care in the heart failure clinic.


OutcomesFunctional status, quality of life, hospitalisation rates, quality of care, drug usage, cost-effectiveness. NYHA Functional Class. Six month follow-up.


NotesMortality not reported. No response from authors for further detail.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"An investigator, unaware of the patients' demographic and clinical profile, using a computer-generated list, initiated randomisation" p68.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)Unclear riskNo evidence of selective outcome reporting.

Was the study powered to detect differences in outcomes.High riskPower calculation not performed.

Were the study groups comparable at baseline?Unclear riskBaseline characteristics were similar between the groups.

Was the study reported according to CONSORT guidelines?Low riskReported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskCHF symptoms and LVEF > 40%.

Riegel 2002

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants358 patients discharged from hospital with heart failure.

Mean age 74 years.

49% of participants were male.

USA.


InterventionsStructured telephone support.

Telephonic case management by a registered nurse using decision support software, involving patient education and counselling and liaison with primary care physician. Patients were telephoned within 5 days of discharge and thereafter at a frequency guided by the software and case manager (mean 17 calls).

Usual care was not standardised, and no formal telephonic case-management was in existence at these institutions. These patients presumably received some education regarding HF management prior to hospital discharge.


OutcomesMortality, rehospitalisation, physician and emergency department visits, inpatient costs, patient satisfaction.

Six month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not stated. (Physicians were the unit of randomisation)

Allocation concealment (selection bias)Low risk"Physicians were not informed of the group to which they were assigned" p706.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.High riskSample size calculation not performed.

Were the study groups comparable at baseline?High riskSome differences in baseline characteristics.

Was the study reported according to CONSORT guidelines?Unclear riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Riegel 2006

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants135 hospitalised Hispanic patients with CHF.

Mean age 72 years.

46% of participants were male.

USA.


InterventionsStructured telephone support.

Education, monitoring and guidance by bilingual-bicultural Mexican-American registered nurses via telephone case management standardised using decision support software. Patients were contacted on average within 5 days of discharge and thereafter at a frequency guided by the software and nurse case manager over a 6 month period (mean 13.5 calls to patients and 8.4 additional calls to families).  Printed educational material was provided monthly and upon request in the relevant language.

Usual care was not standardised and no formal disease management program existed at these institutions. The standard of usual care was that patients were educated regarding HF management before discharge, assuming that the nurse spoke the patient’s language or someone bilingual was available to translate. In reality, only a small portion of staff were bilingual .


OutcomesMortality, re hospitalisation, cost of care, self-reported health-related quality of life and depression.

Six month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.

Meta-analysis performed using number of patients randomised (n = 135).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"After the baseline data were collected, the nurse case manager opened a sealed envelope with the random assignment. These envelopes had been prepared by the project director and attached to the numbered data collection forms, to be opened in sequence" p214.

Method of randomisation not detailed.

Allocation concealment (selection bias)Low riskSee above.

Blinding (performance bias and detection bias)
Intervention
Low risk"We were unable to strictly blind staff about which patients were in the intervention group, but a research assistant uninvolved with the clinical care collected all follow-up data" p214.

Incomplete outcome data (attrition bias)
All outcomes
Low riskFor intervention arm, only 69 participants were included in analysis as one outlier excluded from analysis.

"One outlier was removed from the data set before analyses began because he spent three months in the hospital while his family debated taking him off life support" p214.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.Low riskSample size calculation performed. The study was powered for the primary outcome - HF readmission.

Were the study groups comparable at baseline?Unclear riskComparison not made.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Sisk 2006

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants406 non-Hispanic and Hispanic patients with documented systolic dysfunction.

Mean age 59 years.

54% of participants were male.

USA.


InterventionsStructured telephone support.

An in-person appointment was arranged for each intervention patient, which included symptom and disease education and referral to additional patient services (if required). Follow-up telephone calls consisted of patient assessment, recording of admission information reinforcement of self-monitoring and administration of a food-frequency questionnaire (at 2, 4, 8, 12 and 24 weeks and a report sent to patients). Intervention nurses coordinated flow of information between patient and clinician and arranged medication adjustment and required examinations.

Usual care patients received guidelines for managing systolic dysfunction, but no other care information was specified.


OutcomesMortality, hospitalisations, functional status (including quality of life). Cost

12 month follow-up.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The project's statistician used a computer-generated, random-number sequence without blocking or stratification to centrally determine randomizations assignments and concealed treatment group assignments in sealed, opaque envelopes" p275.

Allocation concealment (selection bias)Low riskSee above.

Blinding (performance bias and detection bias)
Intervention
Unclear riskTo measure hospitalizations, we used billing data from the 4 participating hospitals. At quarterly telephone surveys, interviewers who were blinded to treatment assignment asked patients about hospitalizations at nonparticipating hospitals; however, we present the analysis of billing data because they measure hospitalizations independent of possibly socially acceptable responses or survey non-response of the patients. p276.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses to follow-up in the first 12 months of follow-up.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.Low riskPower calculation performed for sample size - adequately powered for the primary outcome of probability of hospitalisation.

Were the study groups comparable at baseline?Unclear riskGroups were similar.

Was the study reported according to CONSORT guidelines?Unclear riskReported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskSystolic dysfunction on echo, etc.

Soran 2008

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants315 patients with HF diagnosis secondary to systolic dysfunction (LVEF ≤ 40%).

Mean age 76 years.

35% of participants were male.

USA.


InterventionsTelemonitoring.

Patients randomised to the Heart Failure Monitoring System (HFMS) cohort received a disease management program using telecommunication equipment including an electronic scale and individualised symptom response system linked to a database staffed by nurses. Patients weighed themselves and answered questions related to their heart failure. Patients were contacted if any changes were observed in symptoms or weight.

Patients allocated to standard heart failure care (SC) received enhanced patient education, education to clinicians and follow-up. They were provided with a digital home scale to weigh themselves daily and educational materials related to worsening of HF and were asked to record heart failure symptoms.

All patients were telephoned 30 days and 3 months post-randomisation for blinded clinical data collection (vital signs, hospital visits, quality of life questionnaires).


OutcomesTreatment failure (cardiovascular mortality or rehospitalisation for HF within 6 months), length of hospital stay, 6-month all-cause hospitalisation, 6-month heart failure hospitalisation, number of emergency room visits, Medicare expenditure, total patient costs, quality of life.

Six month follow-up.


NotesNumber of patients hospitalised calculated from reported % with any hospital admission.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"...patients were randomised in a 1:1 ratio.." p712.

Method of randomisation not detailed.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Low risk"Patients were also contacted by telephone...by non-medical personnel masked to treatment assignment to collect clinical data..." p713.

"The trial used an independent adjudication event committee to classify deaths, hospitalizations, and adverse events and was monitored by an independent data safety monitoring board..." p712.  

"The HFHC Trial was a multi centre, randomised controlled clinical trial with blinded endpoint evaluation..." p712.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"Eight patients refused to be re contacted after randomisation and were considered lost to follow-up" p713.

"The intention-to-treat principle was used to compare HFMS to SC" p713.

Selective reporting (reporting bias)Low riskNo evidence of selective outcome reporting.

Was the study powered to detect differences in outcomes.Low riskSample size calculation for the primary endpoints was performed. Study was powered for these outcomes - (cardiovascular death or rehospitalization; among patients rehospitalisation for heart failure, length of hospital stay was also considered a primary end point).

Were the study groups comparable at baseline?Low riskNo statistically significant differences in the variables reported.

Was the study reported according to CONSORT guidelines?High riskNot reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskEvidence of systolic dysfunction via a left ventricular ejection fraction of <40% documented by echocardiography, radionuclide ventriculography, or a contrast ventricular angiogram; current symptoms of heart failure including dyspnoea on exertion, orthopnoea, paroxysmal nocturnal dyspnoea, fatigue, abdominal or lower extremity edema or swelling.

Tsuyuki 2004

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants276 patients discharged from hospital with heart failure.

Mean age 72 years.

58% of participants were male.

Canada.


InterventionsStructured telephone support.

Early discharge planning with provision of adherence aids, patient education, regularly scheduled telephone contact with local research coordinator at two and four weeks then monthly thereafter for six months. Recommendations to see primary care physician if not on target dose ACE inhibitor or deterioration.

Patients assigned to usual care received a general heart disease pamphlet before discharge, but no formal counselling beyond what was routine at the hospital. Patients were contacted monthly for six months to ascertain clinical events.


OutcomesMortality, rehospitalisation, medication adherence, physician and emergency department visits, cost-analysis.

6 month follow-up.


NotesIncluded in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“Randomization was conducted by a computer-generated sequence using block randomisation (block size of 4), stratified by study site (hospital)” p475.

Allocation concealment (selection bias)Unclear risk"“...patients were randomised via a telephone call to the project office" p475.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskIntervention: early withdrawal n = 5; lost to follow-up n = 3.

Control: early withdrawal n = 2; lost to follow-up n = 4.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.Low riskSample size calculation performed. Study was powered for the primary outcome - medication adherence.

Were the study groups comparable at baseline?High riskSome variables differed between the groups.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Villani 2007 (ICAROS)

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants120 Patients (LVEF ≤ 40%) NYHA II-III.

Mean age 69 years.

75% of participants were male.

Italy


InterventionsTelemonitoring.

Continuous monitoring of patient parameters (Daily-weight, urine output, fluid intake, blood pressure, heart rate etc.) Hand held transmission device (Smart Phone / PDA) via broadband and wireless. Almarm sounds at medication times.

Regular questionnaires (Anxiety, Depression, Anger)

Usual Care; Conventional management, returned to medico practitioner and placed in a system of visits to clinics and receiving materials at the clinic.


OutcomesMortality, Hospitalisation and Emergency room visits

Cost and improvement in LVEF %

12 months follow-up.


NotesData from Abstract / Conference Proceedings and contact with authors.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Open randomised parallel-groups"

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskUnable to assess.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnable to assess.

Selective reporting (reporting bias)Unclear riskUnable to assess.

Was the study powered to detect differences in outcomes.Unclear riskUnable to assess.

Were the study groups comparable at baseline?Low riskAccording to preliminary data

Was the study reported according to CONSORT guidelines?Unclear riskUnable to assess.

Was the diagnosis of heart failure defined and appropriate?Low riskEchocardiogram LVEF ≤ 40%

Wakefield 2008

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants148 patients hospitalised for HF exacerbation.

Mean age 69 years.

99% of participants were male.

USA.


InterventionsStructured telephone support.

Patients allocated to the intervention group were allocated to 1 of 2 interventions: telephone follow-up or videophone follow-up. Intervention patients were contacted by a nurse 3 times in the first week then weekly for 11 weeks. Symptoms and the patients discharge plan was reviewed and reinforced as well as referrals made if required. Additionally, the intervention nurses employed behaviour skill training strategies to maximise self-management, self-monitoring and self-efficacy.

Usual care was not specified except to state that "subjects contacted their primary care nurse case manager by telephone if needed".


OutcomesMortality, readmissions, hospital days, time to first readmission, urgent care clinic visits, quality of life, intervention dose and technical issues.

12 month follow-up.


NotesTelephone and videophone intervention arms were combined and classed as structured telephone support.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The project coordinator prepared sealed envelopes containing group assignments in blocks of 24" p754.

Allocation concealment (selection bias)Low risk"Following informed consent and baseline data collection, study nurses opened the envelope to assign subjects to one of three treatment conditions: usual care, telephone follow-up, or videophone follow-up” p754.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Low risk"At 3 months, 85% (n = 126) completed follow-up; at 6 months, 74% (n = 109) completed follow-up" p757. 

"All data analyses were conducted using an intent-to-treat approach" p755.

Selective reporting (reporting bias)Low riskSelective outcome reporting not evident.

Was the study powered to detect differences in outcomes.High riskPower calculation performed to determine sample size for readmission at 3 months. Study not powered for this outcome.

Were the study groups comparable at baseline?Low riskNo statistically significant differences between groups at baseline.

Was the study reported according to CONSORT guidelines?Low riskStudy reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Unclear riskNot detailed.

Woodend 2008

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants121 patients with symptomatic heart failure (NYHA Class II or greater).

Mean age 68 years.

74% of participants were male.

Canada.


InterventionsTelemonitoring.

Daily transmission of weight and periodic transmission of ECG and BP. Weekly video conferences by tele-home care nurse. Video conferences more frequent in first few weeks and tapered over the 3 months.

Usual care was not described.


OutcomesMortality (3 months) rehospitalisation, quality of life, emergency department visits, patient satisfaction.

12 month follow-up.


NotesMortality data included in previous systematic review and meta-analysis Clark 2007a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of randomisation not detailed.

Allocation concealment (selection bias)Unclear riskNot detailed.

Blinding (performance bias and detection bias)
Intervention
Unclear riskNot detailed.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot detailed.

Selective reporting (reporting bias)High riskSome nominated outcomes not reported (morbidity).

Was the study powered to detect differences in outcomes.Unclear riskSample size calculation not reported.

Were the study groups comparable at baseline?Low riskThe groups differed at baseline.

Was the study reported according to CONSORT guidelines?High riskStudy not reported according to CONSORT guidelines.

Was the diagnosis of heart failure defined and appropriate?Low riskSymptomatic HF (New York Heart Association [NYHA] Class II or greater.

Zugck 2008 (HiTel)

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.


Participants88 patients recruited from hospital, mean LVEF was 24 ± 7%. Inclusion criteria NYHA II-IV on optimum therapy and telephone at home.

Mean age 58.1 years.

82% of participants were male.

Germany.


InterventionsTelemonitoring.

Intervention group transmitted to monitoring centre via modem vital signs, BP SpO2and received lifestyle and medication education. NYHA III and IV transmitted weekly and NYHA II monthly. Medical advice was available 24/7.

Usual care not described.


OutcomesAll cause hospitalisation.

12 month follow-up.


NotesTranslated from German and English abstracts.

Authors provided further details.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"After screening all patients were randomised with a standard procedure" - correspondence from author.

Allocation concealment (selection bias)High riskUnable to assess.

Blinding (performance bias and detection bias)
Intervention
Unclear riskUnable to assess.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnable to assess.

Selective reporting (reporting bias)Unclear riskUnable to assess.

Was the study powered to detect differences in outcomes.Unclear riskUnable to assess.

Were the study groups comparable at baseline?Unclear riskUnable to assess.

Was the study reported according to CONSORT guidelines?Unclear riskUnable to assess.

Was the diagnosis of heart failure defined and appropriate?Unclear riskUnable to assess.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Akosah 2005Contra to protocol: intervention included frequent clinic visits.

Albanese 2001Contra to protocol: invasive impedence monitoring (SCOOP II Trial Evaluating CRT/ICD/Impedence Monitoring).

Albert 2007Contra to protocol: intervention was an education video.

Aliti 2007Discussion paper.

Anderson 2005Contra to protocol: intervention was a heart failure clinic.

Artinian 2003Contra to protocol: web-based intervention, not an RCT.

Artinian 2006Contra to protocol: intervention specific for hypertension, not heart failure.

Arya 2008Contra to protocol: invasive haemodynamic monitoring.

Baden 2007aContra to protcol: not an RCT.

Baden 2007bContra to protocol: not an RCT.

Baer 1999Asessment of correlation between electronic patient measurements and manual nurse measurements.

Baldauf 2008Contra to protocol: not an RCT.

Barber 1999Contra to protocol: not an RCT, quasi experimental design.

Benatar 2003Contra to protocol: comparison was between telemonitoring and home visits (not usual care).

Bennett 2006Contra to protcol: intervention was a computer-based intervention.

Blue 2001Contra to protocol: intervention included home visits.

Bocchi 2007 (REMADHE)Contra to protocol: intervention involved intensive group education sessions and face-to-face individual/group communication.

Bolz 2005Review paper.

Bondmass 1999Contra to protocol: not an RCT.

Bondmass 2002Contra to protocol: not an RCT.

Bondmass 2007Contra to protocol: not an RCT.

Bourge 2008 (COMPASS-HF)Contra to protocol: invasive implantable haemodynamic monitoring.

Bowles 2007Reivew paper.

Bowles 2008Systematic review.

Boyne 2008Contra to protocol: not an RCT, pre- and post-test study design.

Brennan 2006Contra to protcol: not an RCT.

Brownsell 2006aAuthor contacted: primary and secondary outcomes for this review were not measured.

Brownsell 2006bAuthor contacted: primary and secondary outcomes for this review were not measured.

Brownsell 2008Author contacted: primary and secondary outcomes for this review were not measured.

Caldwell 2005Contra to protocol: education session with one follow-up telephone call.

Calvin 2008Contra to protocol: participants received 18 education sessions aimed to develop self-management skills. The intervention did not include telemonitoring or structured telephone support.

Capomolla 2002Contra to protocol: intervention was a day hospital.

Cherry 2000Review article.

Chetney 2003Contra to protocol: not an RCT.

Chetney 2008Contra to protocol: not an RCT.

Clappers 2006Review of abstracts.

Clark 2008Interviews with carers of patients with heart failure regarding their experiences.

Clarke 2005Conference discussion paper.

Cline 1998Contra to protocol: Intervention group received education on heart failure and self management, with follow up at an outpatient clinic.

Cole 2006Contra to protocol: not an RCT.

Cordisco 1999Contra to protocol: not an RCT.

Courtney 2009Contra to protcol: intervention was an exercise programme.

Cross 1999Contra to protocol: not an RCT.

Dalmiani 2001Contra to protcol: not an RCT.

Dang 2006Contra to protocol: not an RCT.

Dansky 2008aContra to protocol: intervention included home visits.

Dansky 2008bContra to protocol: not an RCT.

Dar 2009 (HOME-HF)Contra to protocol: both study groups recieved a home visit from study nurse.

de Feo 2002Contra to protocol: not an RCT.

Dedier 2008Contra to protocol: intervention specific for hypertension, not heart failure.

Deepak 2008Contra to protocol: not an RCT.

Del Sindaco 2007Contra to protocol: intervention included clinic and home visits.

Demarzo 2006Contra to protocol: invasive haemodynamic monitoring.

Dimmick 2003Contra to protocol: not an RCT.

Dollard 2004Review paper.

Dougherty 2005Contra to protocol: invasive monitoring.

Doughty 2002Contra to protocol: intervention included regular clinic visits.

Downey 2001Contra to protocol: not an RCT.

Ducharme 2005Contra to protocol: intervention was an outpatient clinic.

Duffy 2005Contra to protocol: intervention included home visits.

Duffy 2008Discussion paper.

Dunagan 2005Contra to protocol: intervention included home visits.

Dunn 2006Contra to protocol: not an RCT, intervention included clinic visits.

Dunn 2007Contra to protocol: not an RCT, intervention included clinic visits.

Ekman 1998Contra to protocol: intervention was a nurse-led outpatient clinic and telephone follow-up.

Ellery 2006Contra to protocol: intervention was invasive monitoring.

Evangelista 2004Contra to protocol: web-based education and counseling for patients with heart failure.

Feldman 2004Contra to protocol: intervention was email-communication to nurses.

Feldman 2005Contra to protocol: intervention was email-communication to nurses.

Finkelstein 2004Contra to protocol: intervention included home visits.

Finkelstein 2006Contra to protocol: intervention included home visits.

Foley 2008Contra to protocol: not an RCT.

Fragrasso 2007Not an intervention for management of heart failure, validation of remote clinical examination.

Friedberg 2008Review of COACH study.

Fursse 2008Contra to protocol: not an RCT.

Gambetta 2007Contra to protocol: not an RCT.

Grancelli 2007Editorial for previous version of this review.

Gregory 2006 (SPAN-CHF)Contra to protocol: intervention included home visits.

Gund 2008Contra to protocol: not an RCT.

Hanssen 2007Contra to protocol: intervention was telephone follow-up of patients following a myocardial infarction.

Harkness 2006Review of DIAL Trial.

Harrison 2002Contra to protocol: intervention included home visits.

Hart-Wright 2006Contra to protocol: not an RCT.

Heidenreich 1999Contra to protocol: not an RCT.

Heisler 2007Contra to protocol: not an RCT.

Helms 2007Discussion / review paper.

Ho 2007Contra to protocol: intervention included home visits.

Holst 2007Contra to protocol: not structured telephone support or telemonitoring, telephone follow-up following an education intervention.

Hoover 2007Contra to protocol: not an RCT.

Hudson 2005Contra to protocol: not an RCT.

Huynh 2006Contra to protocol: intensive education session; not structured telephone support or telemonitoring.

Jaarsma (COACH Study)Contra to protocol: intervention included clinic and home visits.

Jaarsma 1999Review paper.

Jenkins 2001Contra to protocol: intervention included home visits.

Jerant 2001Contra to protocol: intervention included home visits.

Jerant 2003Contra to protocol: intervention included home visits.

Johnston 2000Intervention not specific to heart failure patients.

Jolly 2007Home-based exercise intervention.

Jones 2002Review paper.

Karlsson 2005Contra to protocol: intervention was an outpatient clinic.

Kashem 2007Contra to protocol: web-based intervention.

Kasper 2002Contra to protocol: intervention included home viists.

Khoury 2008Contra to protocol: invasive haemodynamic monitoring.

Kimmelsteil 2004Contra to protocol: intervention included home visits.

Kirschner 2006Discussion paper.

Kline 2006Contra to protocol: not an RCT.

Koehler 2006Review of TEN-HMS study.

Koelling 2005Contra to protocol: intervention was a face-to-face education session.

Kottmair 2005Discussion paper.

Koutkias 2003Contra to protocol: not an RCT.

Krumholz 2002Contra to protocol: frequent clinic and home visits.

Kutzleb 2006Contra to protocol: not an RCT.

Kwok 2008Contra to protcol: intervention included home visits.

LaFramboise 2003Contra to protocol: not an RCT.

Lehmann 2006Contra to protocol: not an RCT.

Lucas 2007Contra to protocol: not an RCT.

Machingo 2003Contra to protocol: not an RCT.

Maddukuri 2006Contra to protocol: not an RCT.

Madigan 2008Contra to protcol: not an RCT.

Maglaveras 2002Contra to protocol:Not RCT

Maglaveras 2003Contra to protocol: not an RCT

Maglaveras 2006Contra to protocol: not an RCT

Mair 2007Review paper.

Makaya 2008Contra to protocol: intervention included home visits.

Mansfield 2006Contra to protocol: not an RCT.

Marangelli 2007Contra to protocol: not an RCT.

Martensson 2005Contra to protocol: intervention included home visits.

Mau 2006Contra to protocol: intervention included home visits.

McCauley 2006Contra to protocol: intervention included home visits.

McCoy 2007Contra to protocol: intervention included home visits.

McDonald 2002Contra to protocol: frequent clinic visits with unstructured telephone follow-up.

McManus 2004Contra to protocol: not an RCT.

Mendoza 2002Contra to protocol: not an RCT.

Mistiaen 2006Review paper.

Morales-Ascencio 2008Contra to protocol: not an RCT.

Morcillo 2005Intervention was a single, home-based educational intervention.

Morguet 2006Contra to protocol: not an RCT.

Morguet 2007aContra to protocol: not an RCT.

Morguet 2007bContra to protocol: not an RCT.

Morguet 2008Contra to protocol: not RCT.

Mueller 2002Contra to protocol: not an RCT.

Murtaugh 2005Contra to protocol: intervention was email-communication to nurses.

Myers 2006Contra to protocol: not an RCT.

Nanevicz 2000Contra to protocol: not an RCT.

Naylor 1999Contra to protocol: intervention included home visits.

Naylor 2004Contra to protocol: intervention included home visits.

Nguyen 2007Contra to protocol: not an RCT.

Nobel 2003Contra to protocol: not an RCT.

Noel 2004Contra to protocol: intervention not specific to patients with heart failure.

Nohria 2007Contra to protocol: intervention was invasive haemodynamic monitoring.

Nucifora 2006Contra to protocol: intervention was not structured telphone support (a telephone number was available for patients to talk to a nurse).

O'Reilly 1999Contra to protocol: not an RCT.

Oddone 1999Contra to protocol: not an RCT.

Oeff 2005aContra to protocol: not an RCT.

Oeff 2005bDiscussion paper.

Ojeda 2005Contra to protocol: intervention included clinic visits. A telephone number was made available to patients to contact clinic staff.

Opasich 2005Review paper.

Pasqualini 2006Contra to protocol: not an RCT.

Philbin 2000Report on a quality improvement intervention.

Phillips 2008Report of a 24 hour telephone support program for patients and caregivers at the end of life.

Picard 2008Review paper.

Piepoli 2006Contra to protocol: not an RCT.

Piorkowski 2006Contra to protocol: invasive haemodynamic monitoring.

Pugh 2001Contra to protocol: nurse visits were part of the intervention.

Quinn 2006Contra to protocol: not an RCT.

Quinn 2008Contra to protocol: not an RCT.

Rabelo 2007Contra to protocol: not an RCT.

Rahimpour 2008Contra to protocol: not an RCT.

Reble 2006Contra to protocol: not an RCT.

Repoley 2006Contra to protocol: not an RCT.

Rich 2002Review paper.

Ross 2004Comparison of interactive internet electronic record.

Roth 2005Contra to protocol: not an RCT, not specific to heart failure.

Roth 2006Contra to protocol: not an RCT, not specific to heart failure.

Rozenman 2007Contra to protocol: invasive haemodynamic monitoring.

Saxon 2007Contra to protocol: invasive haemodynamic monitoring.

Scalvini 2004Contra to protocol: not an RCT.

Scalvini 2005aContra to protocol: not an RCT.

Scalvini 2005bContra to protocol: not an RCT.

Scalvini 2006Contra to protocol: GP monitoring vs home based monitoring.

Scherr 2006Contra to protocol:intervention not specific for heart failure patients.

Schmidt 2008Medication box which monitored medication adherance.

Schneider 2004Contra to protocol: not an RCT.

Schofield 2005Contra to protocol: not an RCT.

Schofield 2008Contra to protocol: not an RCT.

Schwarz 2008Contra to protocol: intervention involved caregivers as well as the patient with heart failure.

Scott 2004Contra to protocol: not an RCT.

Seibert 2008aContra to protocol: not an RCT.

Serxner 1998Contra to protocol: not an RCT.

Shah 2007Discussion paper.

Shah 2008Contra to protocol: intervention based in clinic.

Shearer 2007Author contacted: primary and secondary outcomes for this review were not measured.

Simpson 2006Heart transplant technology.

Slater 2006Contra to protocol: not an RCT.

Slater 2008Contra to protocol: not an RCT.

Smart 2005Contra to protocol: not an RCT.

Smeulders 2006Contra to protocol: intervention based in clinic.

Spaeder 2006Contra to protocol: very frequent clinic visits.

Sprenger 2007Contra to protocol: not an RCT.

Steckler 2008Contra to protocol: not an RCT.

Stromberg 2003Contra to protocol: intervention based in clinic.

Stromberg 2006Contra to protocol: intervention based in clinic.

Sullivan 2006Contra to protocol: not an RCT.

Terschuren 2007Contra to protocol: not an RCT.

Thompson 2005Contra to protocol: intervention included home and clinic visits.

Thompson 2008Review of Woodend 2003.

Tramarin 2005Collection of abstracts, not relating to structured telephone support or telemonitoring in heart failure.

Trudel 2007Study included patients with diabetes and hypertension. Intervention not specific to heart failure.

VA Technology AssessmentReport on telemonitoring technologies.

Vaccaro 2001Contra to protocol: not an RCT. Compared 638 matched controls.

Valle 2004Contra to procotol: intervention consisted of education for patient and family, prescribed diet and guideline-based pharmacotherapy and did not include structured telephone support or telemonitoring.

van den Bussche 2004Contra to protocol: not an RCT, observation study.

Villalba 2006aContra to protocol: not an RCT.

Villalba 2006bContra to protocol: not an RCT.

Vrijhoef 2007Contra to protocol: not an RCT.

Waldman 2008Included patients with coronary artery disease, intervention not specific to heart failure.

Walsh 2005Contra to protocol: not an RCT.

Waywell 2007Contra to protocol: not an RCT.

Weintraub 2005Contra to protocol: intervention included home-visits.

West-Frasier 2008Contra to protocol: home visits by cardiac nurses to both groups (communication from author).

Westlake 2007Contra to protocol: intervention was web-based.

Wheeler 2006Contra to protocol: intervention included home visits.

Whitten 2007Review.

Wierzchowiecki 2005Contra to protocol: intervention included home visits.

Wierzchowiecki 2006Contra to protocol: intervention included home visits.

Willyard 2006Contra to protocol: not an RCT.

Wong 2005Intervention for patients with chronic obstructive pulmonary disease.

Wongpiriyayothar 2008Contra to protocol: intervention included home visits.

Wright 2003Contra to protocol: intervention consisted of symptom diary, attended three education session and clinic visits.

Wu 2006Comparison of internet-based technology.

Zaphiriou 2006Contra to protocol: intervention included a home visit.

Zentner 2007Contra to protocol: not an RCT.

Zugck 2006Contra to protocol: not an RCT.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Dunlap 2006 (HearT-I)

MethodsRandomised controlled trial; Intervention versus usual care

Participants455 patients to date (NYHA Class II or greater).

Mean age no data.

% of participants were male - no data.

USA.

InterventionsStructured Telephone Support

Three components; 10 computer initiated medication refill and clinic appointment reminders; 2) IVR access to education modules 3) Computer initiated phone calls with a series of question regarding weight and symptom

OutcomesAll cause hospitalisation; Unscheduled outpatient visits.

KCCQ; Satisfaction; Adherence to medications; knowledge of self care and heart failure

12 months follow-up.

NotesUnable to contact authors to determine or clarify intervention and usual care arms

Levine2006(Mind My Heart)

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.

Participants234 patients

Mean age not reported.

% of participants were male- not reported.

USA.

InterventionsTelemonitoring.

Intervention group transmitted to monitoring centre via modem vital signs, BP SpO2.

Usual care no further contact with project staff.

OutcomesTechnology use and Satisfaction Survey

NotesNo primary outcomes reported. Unable to contact authors

Scherr 2005 (MobiTEL)

MethodsOpen randomised controlled trial; Intervention versus usual care

Participants57 = 28 Telemonitoring / 29 Usual Care patients (NYHA Class II or greater).

Recruiting on-going at time of report

Mean age 63 years.

% of participants were male - no data.

Austria.

InterventionsTelemonitoring

Mobile phone and digital weight scale; data transferred to telemonitoring centre

OutcomesCombined end-point of CVD mortality and CHF hospitalisation

NYHF Class; MLWHFQ; Cost Effectiveness

Six months follow-up.

NotesPublished after census data of review. Primary outcomes only reported as combined outcomes

Yakushin 2006

MethodsRandomised controlled trial; intervention arm and control (usual care) arm.

Participants78 patients

Mean age 56 years.

% of participants were male-not reported.

Russian Federation.

InterventionsUnable to determine intervention from abstract

Some telephone follow-up

Usual care not described.

OutcomesHospitalisations and Cardiovascular death

NotesUnable to contact authors

 
Characteristics of ongoing studies [ordered by study ID]
Chaudhry 2007 (Tele-HF)

Trial name or titleTelemonitoring to Improve Heart Failure (Tele-HF)

MethodsRandomised control trial

Centralised randomisation performed by telephone stratified by study site and force randomised within each study site in blocks of 20 (10 intervention: 10 control)

Power calculated for all-cause mortality and hospitalisation. 1640 participants (820 in each group)

ParticipantsDischarged from a HF hospitalisation within 30 days of enrolment in the study

Exclusion < 18 years, No English or Spanish, < 6 months predicted survival

InterventionsStructured telephone support.

Participants made daily toll-free call to an automated system with pre-recorded surveys about daily weight and symptoms (Pharos Innovations, Chicago)

Data downloads were viewed daily for variances and patients contacted by phone for follow-up

Usual Care Discharge follow-up with Physician and discussion of guidelines

OutcomesFollow-up 6 months

All cause morality

All cause re-admission

Starting dateStudy is now completed. Results due in approximately 12 months.

Contact informationDr Sarwat I Chaudhry , Yale University School of Medicine,

PO Box 208025 New Haven CT 06520-8025

NotesFinal results not published

Kohler 2006

Trial name or titlePartnership for the Heart -the Heart Coach System

MethodsA randomised prospective multi-centre study

Participants450 patients with chronic heart failure NYHA Function Class II-III

InterventionsThe German Federal Ministry of Econmics and Technology launched an invitation to tender for a telemonitoring platform system (ww.nextgenerationmedia.de). The total cost of the project is €8 million (grant €4.9 million) The aim is to demonstrate the superiority of a telemedicine home care monitoring system.

OutcomesPrimary endpoints Mortality, duration of inpatient treatment and costs.

Secondary Endpoints quality of life.

Starting date2005-2008

Contact informationFriedrich Köhler MD, Charite-Universitätsmedizin Berlin,

friedrich.koehler@charite.de

NotesAwaiting contact from authors for further details or publications

Kulshreshtha 2008a

Trial name or titleRemote Monitoring Program

MethodsRandomised control trial

Participants150 Eligible patients from Massachusetts General Hospital

InterventionsParticipants transmitted daily vital signs data and weight to a nurse who coordinated care with a physician. Timely interventions and teaching were offered over the course of the 6 month study.

OutcomesAll cause readmission

HF related admission mortality ER Visits and Lenght of Stay

Starting date2008

Contact informationDr Ambar Kulshreshtha, Harvard Medical School, Boston MA

NotesOnly abstract available. No response after several attempts to contact authors.

 
Table 1. Duration of follow-up, Length of Stay, QOL, Cost, Adherence, Acceptability and all other outcome measures

Study

(year)
Endpoint Hospital Length of StayHealth and Quality of Life*Effect on

Cost /case
Cost of the

Intervention
Acceptability of Intervention

to Patients and “Other” Measures

Both Structured Telephone Support and Telemonitoring      

Cleland et al. (2005) TEN-HMS Study

 

QoL report: Louis et al. (2006)
240 days

400 days ∂
LOS for heart failure hospitalisations (240 days)

(Median IQR)

UC=11 ( 6-20)

NTS =15 (7-29)

HTM= 11(6-19)
---"A total of 81% of patients assigned randomly to HTM had 80% compliance with at least one daily measurement (weight or blood pressure), and 55% had 80% compliance with twice daily measurements." p1659.

"Overall patient acceptance was good at 91.2%." p537A.

"96% of patients were well satisfied with the system and 97% found the tele-care devices easy to use." p537A.

"...4.1% of patients refused to accept the technology in their homes while 2.9% of patients asked for the equipment to be removed and 1.8% discontinued recording." p537A.

Mortara et al. (2009) HHH Study11.6 months (mean)Over the 12 month follow-up

Total days in hospital for HF, UC 584 days  (1.0%) vs. HT 1175 Days(1.1%), HT1 477 (1.2%), HT2 374(1.2%), HT3 324 (1.0%)

NS in reducing bed days
---"Patients completed 81%...of all practicable vital signs transmissions from home." p315.

"Overall, 92% of practicable recordings were carried out by the patients...confirming high feasibility". p315.

 

Structured Telephone Support

 
      

Angermann et al.

(2007) INH Study
6 months-[UPWARDS ARROW] SF-36

Age and sex adjusted physical functioning (P = 0.036) and physical health (P = 0.03)
--Improved NYHA classification (P = 0.029).

Barth (2001)2 months-[UPWARDS ARROW]MLWHFQ§ (P = 0.0005)

 
-US $23.60/ patient-

DeBusk et al. (2004)12 months- 

 -

 
--"No statistically significant between-group differences in the use of angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, beta-blockers, diuretics, or digitalis were noted at any time." p609.

DeWalt et al. (2006)12 months-Modified MLWHFQ§ to account for all literacy levels (NS)

S-TOFHLA (NS)
--HF knowledge improved (P = 0.001)

Self-efficacy improved 2 points (P = 0.0026)

Self-care behaviour improved (P < 0.001)

Galbreath et al. (2004)

QOL report:Smith et al. (2005)

Cost-effectiveness report Smith et al. (2008)
18 monthsNo statistical changes for in patient bed days between groups

P value  for group effect 0.899

P value for time effect 0.117
"Analysis of the SF-36 health transition measure showed a positive effect of the intervention on self-reported improvement in health at 6 months and at 12 months (P = 0.04 and P = 0.004, respectively). However, no effect of disease management was observed across any of the SF-36 components. Women and patients with diastolic heart failure had poorer HRQL scores." p701.NS difference in total healthcare costs.-6 minute walk test (NS)

LVEF (NS)

NYHA functional class  (P < 0.001)

[UPWARDS ARROW] Evidence based pharmacotherapy (P = 0.002)

Gattis et al. (1999)

PHARM Study
6 months----Intervention group closer to target ACEI dose (P < 0.001).

 

GESICA Investigators

(2005) DIAL Trial
16 months

(mean)
-Improved MLWHFQ§  Mean total score, intervention vs. control 30.6 vs. 35.0, mean difference =4.4, 95% confidence interval 1.8 to 6.9, P = 0.001--Increased evidence based pharmacotherapy for CHF.

Increase in dietary compliance.

Krum (2009)

CHAT Study

 

Adherence, adaptation, acceptance report: Clark et al. (2007)

 
12 months_ ---Adherence 65.8%.

Adaptation 97%.

Participants rated the CHAT project with a total acceptability rate of 76.45%.

Laramee et al. (2003)

 
3 monthsLOS Intervention vs Control: mean (SD) 6.9 (6.5) vs. 9.5 (9.8), P = 0.15-Reduction US $2482/ patient (average).US $228.52/ patient (average)Adherence to treatment (daily weighs) (P < 0.01).

Adherence to medications (P = 0.04).

Satisfaction (P < 0.01).

[UPWARDS ARROW]patients taking target doses of ACEI and beta-blockers.

Rainville (1999)

 
12 months----"Functional assessment scores (using the Darthmouth Primary Care Cooperative Information Project) improved slightly in the intervention group but there was no significant change at 30 or 90 days after discharge for either group". p1340-1.

Ramachandran et al. (2007)6 months-[UPWARDS ARROW]KCCQ (P < 0.05)Cost saving

INR 14,592 per patient annually.
-Improvement in NYHA functional class (P = 0.004).

Improvement in 6 minute walk test (P < 0.02).

Slightly higher ACEi/ARB dose in intervention group at study end (P < 0.05).  

There was a feeling of self-control that the patients in the intervention group acquired through the programme. Additionally, there was a feeling of accessibility to a strong support system.

Riegel et al. (2002)6 monthsHF hospital days (6 months)   Intervention vs. Control: mean (SD)

1.1(3.1) vs. 2.1 (4.6) P = 0.05 (with covariate)

All-cause days (6 months)   Intervention vs. Control: mean (SD)

3.5 (6.6) 4.8 (8.3)

P = 0.23 (with covariate)
-46% reduction in inpatient costs  (P = 0.04).$US443 / patient“Patient satisfaction was significantly higher among persons assigned to the intervention group than among those assigned to the usual-care group.” (P = 0.01) p708.

Riegel et al. (2006)

 
6 monthsHF hospital days (6 months)   Intervention vs. Control: mean (SD, 95% CI)

3.40(7.1, CI 1.6-5.2) vs. 3.65 (7.8, 1.9-5.4) 

NS
MLWHFQ§, EQ-5D (NS)NS difference in HF cost of care or all-cause hospital costs.-Depression (NS).

Sisk et al. (2006)

Qol and cost effectiveness report: Herbert et al. (2008)

 
12 months-"Compared with UC patients...(intervention)...patients reported better functioning on both SF-12 (physical component score) (39.9 vs. 36.3, difference 3.6 [CI 1.2 to 6.1] and MLWHFQ§ (38.6 vs. 47.3, difference -8.8 [CI -15.3 to -2.2])" p280."A nurse-led disease management program for patients with heart failure improved quality of life at an expected cost to society of under $25,000 per QALY gained." p545."The intervention cost $2177 per patient were more than offset by reduced hospital costs ($2378 per patient) but higher costs for outpatient procedures, medications, and home health care prevented the intervention from being cost-saving over the 12-month study." p545.-

Tsuyuki et al. (2004)

 
6 monthsCardiovascular hospital days (6 months)   Intervention vs. UC:  mean (SD)

6.4 (6.0) vs. 11.6 (10.3) P = 0.003

Total days 341 vs. 812 P = 0.003

All cause days (6 months)   Intervention vs. UC 

Total days

627 vs.1082 P = 0.001

 
-$CAD2531 per patient reduction.--

Wakefield et al. (2008)

 
12 months"There was no significant differences in the mean number of hospital days between... groups." p758.[UPWARDS ARROW]MLWHFQ§ (in all groups P = 0.0002)Mean HF-related readmission costs were 86% and 84% lower in the videophone and telephone groups, respectively, compared to UC.-Satisfaction between video and telephone (NS).

Nurse perceptions on the difference in interactions between video and telephone (NS).

 

Telemonitoring

 

 
      

Antonicelli et al.

(2008)
12 months-SF-36 (NS)

Except for reported health perception in intervention group, P < 0.046)
---

Balk et al. (2008)

 
288 days (mean)Total days in hospital

Intervention vs. Control

759 (0-116) vs. 762(0-132)

Mean  7.4 vs. 7.9

P value not reported.
SF-36, Dutch version of MLWHFQ§ (NS).

"No differences in quality of life and self care behaviour
were found between the Control group and the Intervention group either at the start or at the end of the study." p1140.
NS difference but "...a trend towards a reduction in contacts with health professionals in intervention group." p1140.Increase in costs in the Intervention group. No decrease in healthcare costs in the intervention group, but the cost of the telemonitoring system increased the total costs in the intervention group."Knowledge about heart failure... increased significantly more in the Intervention group (P< 0.001)." p1136.

"The ease of use was rated very good or good by 80% of the users. Seventy percent of the users mentioned that their access to doctors and nurses was better with remote patient management compared to the service they had received before". p1140.

Blum et al. (2007)

 
794 days (2 years)-Scores with the MLWHFQ§ improved (P = 0.001)

SF36 Mental composite and Physical composites improved (P = 0.001 & P = 0.003)

 
 -Not yet available.BNP, renal function and weight showed significant improvements over time (P =0.011, 0.001 and 0.003).

Capomolla et al. (2004)12 months- - - -"The compliance to telemonitoring was 82%." pF91.

de Lusignan et al.

(2001)
12 months-‡CHFSQ (NS¶)

+GHQ
--"The telemedicine group was sufficiently motivated to record their weight 75% of the time". p725.

"Blood pressure was measured 90% of the time". p725.

"Video link over standard telephone lines was not found to be useful by the patients in the study". p727.

Giordano et al. (2009)

 
12 months--35% reduction in mean cost for readmission in intervention group (843 EUR compared to 1298 EUR in UC group, P < 0.01).Daily cost per patient of intervention was 0.65 EUR and mean annual cost per patient was 185 EUR.-

Goldberg et al. (2003)

WHARF Trial

 
6 months

(mean)
-MLWHFQ§, SF-12, HDS. All scores were improved but were not statistically significant--"Compliance with the monitoring system in the AlereNet arm was 98.5%." p707.

 

Kielblock et al. (2007) and Blasius (2008)12 months--Hospital care expenditures for treatment group were 45% lower (P = 0.01) but medication expenditure was 15% higher (NS). Overall, health care costs were 39.5% lower (6.800 EUR /patient/ yr) in treatment group (P = 0.05).Reduction in hospital costs of 7128 EUR per patient (P = 0.01), but an increase in drug expenditure of 245 EUR per patient (NS).

Highest cost in death group
The satisfaction survey revealed that 57% of those surveyed considered the programme to be “very good” and 43% “quite good”. None of those surveyed responded with “not so good” or “not at all”.

Increased compliance in taking medicines.

Villani et al.   (2007)6 monthsIntervention vs. UC

214 (6.29 days per patient) vs. 701 (15.57 days per patient)
 - - --

Soran et al. (2008)6 monthsHF hospital days (6 months)   Intervention vs. Control  Mean (SD)

9.3 (12.2) vs. 10.0 (7.3) P = 0.22
SF-12, KCCQ (NS)No significant group differences were
found in heart failure cost of care or cost.
-Compliance 97%.

Woodend et al. (2008)

 
12 monthsIntervention patients spent 7.13 vs. 6.71 days (control patients) in hospital in 1 year.Improved MLWHFQ§ (P = 0.025)

SF-36 improved (P < 0.05)

Patients receiving telemonitoring consistently reported higher levels of treatment satisfaction. Increase exertional capacity.
-Overall patients found the equipment easy to use.

Obtaining ECG most difficult.

"Satisfaction was calculated on the sum of scores of 10 questions. The mean scores were 92-97=very highly satisfied." p25.

Zugck et al. (2008)

HiTel Trial
12 monthsSignificant reduced in duration in hospitalisation both comparing telemedicine (UCT+HCT) vs. UC Mean (SD) 1.5 (4.2) vs. 5.1(7.7) days P = 0.05----


1 Euro = approx$CAD 1.55$US1.46£UK0.09$Aust 1.6068.3 INR (Indian Rupee)

 *Health related quality of life, variance between baseline and study endpoint, details provided as included in study; ‡CHFSQ, Chronic Heart Failure Symptomatology Questionnaire;+ General Health Questionnaire GHQ § MLWHFQ, Minnesota Living with Heart Failure Questionnaire; KCCQ, Kansas City Cardiomyopathy Questionnaire; SF-12, Short Form 12 Item; SF-36, Short Form 36 Item; HDS, Health Distress Score; NS, not statistically significant; ∂ Patient acceptability measured at 400 days.  Blank cells indicate no data available for variable. 95% CI = 95% confidence Intervals.