Assessing the acceptability and efficacy of teens taking charge: Transplant—A pilot randomized control trial

Adolescents who have undergone SOT are at heightened risk for graft failure. This pilot randomized controlled trial aimed to determine the feasibility and obtain preliminary estimates of efficacy of the online TTC program.

Adolescents are expected to adhere to stringent regimes posttransplantation for many aspects of their care, including medication, physical exercise, and diet. 5,6 Inadequate self-management and coping skills can lead to poor health outcomes in adolescent patients, 7 and unfortunately, these challenges can continue into adulthood. 8,9 Patients undergoing SOT during adolescence demonstrate poorer long-term graft survival, which may be indicative of the non-linear process of developing self-management skills in this population. 10,11 Therefore, timely adherence-promoting interventions aimed at improving medical outcomes and quality of life are critical. 12 Technology is an integral part of adolescent daily life. Studies show-ingthat95%ofadolescentsaged12-17yearsintheUnitedStatesare Internet users 13 underscore the need to develop technology-based interventions for adolescents. 14 Patients with SOT and chronic illness have been shown to be receptive of health technology programs targeting both medication adherence and web-based peer support programs. 15,16 High school-aged patients regularly access health information online at home and at school, 17 and due to the frequency of Internet use, eHealth programs have the potential to help teen patients better follow their medical regimens and positively impact quality of life, self-efficacy, health education, and overall adherence. 14 For example, a pilot study including patients with juvenile idiopathic arthritis investigated the use of a similar "Teens Take Charge: Managing Arthritis Online" program developed at our institution. 18 They found the program helped to decrease pain, increase knowledge, and improve adherence to exercise compared to attention control group. Our online program was adapted from this previous pilot study.
Thus, there is a clinical need to develop a reliable and comprehensive online program designed to address self-management and target adherence barriers in adolescents who have undergone SOT, which potentially may lead to a reduction in health-related costs. Based on a previously conducted needs assessment and a usability testing study, 2,19 the TTC program was developed. This pilot study had the following aims: 1. Determine study feasibility in terms of accrual and dropout rates, completion of outcome measures, and usage of TTC program.
2. Obtain preliminary estimates of efficacy of the TTC program among a group of pre-or post-transplant adolescents across the following health-related measures: self-management, self-efficacy, mood, use of healthcare services, knowledge, and medication adherence. We hypothesize that the intervention group (who access TTC) will demonstrate greater gains in these healthrelated variables compared to the control group.
3. Conduct interviews with participants in the intervention group following study completion to capture their experiences and perceptions regarding acceptability of the program.

| Participants
Eligible participants were identified and recruited at a large tertiary pediatric hospital in Canada. Participants were recruited from ambulatory renal and liver transplant clinics and from the chronic kidney disease and dialysis clinics between September 2014 and July 2016. Initially, patients were only recruited to the study if they were a minimum of 1-year post-transplant. However, following review of Google Analytics data of the enrolled intervention participants approximately halfway through the enrollment, a decision was made to include pre-and recently transplanted patients (ie, <1 year) into the pilot study. This was due to participants' website usage being lower than expected; it was hoped that pretransplant and more recently transplanted patients would be more motivated to use the website.
Eligibility criteria for the study included: (a) proficiency in the English language; (b) undergone kidney or liver transplant or listed for kidney or liver transplantation; (c) aged 12-18 years; and (d) no significant intellectual or learning delay.    Semi-structured interviews were conducted following study conclusion with intervention group participants. Interviews were conducted by the research project coordinator, either face-to-face or by telephone, to obtain feedback about participants' experience (acceptability) with the online intervention.

| Intervention group
Following group allocation, those randomized to the intervention group were contacted via e-mail with website access instructions.
Intervention group participants were assigned a unique login and password to access the TTC online program, which was restricted to intervention group participants and research team members.
Participants were instructed to visit the intervention website program for at least 1 h/wk but were encouraged to access the site as much as they liked during the study.

| Control group
The control group were not given access to the TTC program.
Widely available web-based materials (Appendix 1) were provided for control group participants that are routinely provided to all patients undergoing kidney or liver transplant, consisting of health-related websites with information about SOT and self-management. Participants randomized to the control group were told that they had the option of looking at these materials, but it was not mandatory.

| Phone call check-ins
Phone calls at 1-and 2-month intervals were made to participants in both groups to maintain engagement in the research study. Using a standardized script, participants in the intervention group were asked about frequency and duration of online program use and if any barriers prevented them from using the site as per study procedures.
Participants in the control group were asked if they had accessed the online materials provided to them or if they had sought any online information related to their health.

| Demographic questionnaire
Participants in both study groups completed a demographic questionnaire including details of their age, gender, type of transplant, and amount of time typically spent on the computer and using the Internet per week.

| Use of the TTC program
Total minutes that intervention participants spent on the TTC website were recorded, with data obtained at three time points using Google Analytics. The differences in total use of the website across intervention group participants who were waiting for transplantation and who had received a SOT were reviewed. Compiled reports Analytics during the study, and website activity for each participant was tracked using a unique ID.

| Health-related variables
All outcome measures were self-report.

Medical Self-Management and Transition Readiness Scale
The Medical Self-Management and Transition Readiness scale has been shown to be reliable and valid. 21 Internal consistencies using Cronbach's alpha were high for youth at 0.89. Inter-rater reliability when measured between youth and parent report was r = .56 (P < .1). This questionnaire includes 22 items using a three-item Likert scale where "0" indicates "No, I can't," "2" indicates "some but not all," and "3" indicates "Yes I can". 21 Domains on this scale included the ability, knowledge, and participation in engaging with healthcare appointments and responsibilities. Scores range from minimum of 0 to a maximum of 66, with higher scores denoting greater independence.

Self-efficacy (Generalized Self-Efficacy Sherer Scale)
The GSE scale is a 12-item Likert format scale that measures selfefficacy relating to general independence. The responses are on a five-point scale ranging from "1" denoting "strongly disagree" to "5" denoting "strongly agree." Higher total scores represent greater levels of self-efficacy. Validity and reliability of the GSE has been explored in previous research. 22,23 Internal consistency is good for adolescents with α = 0.87. An example of a statement from this F I G U R E 2 Tablewithmodules1-7name,typeofinformationcoveredinmodule,graphichighlights,andtoolsavailable scale includes: "if I can't do a job the first time, I keep trying until I can."

PROMIS pediatric anxiety and depression short form
Two separate eight-item short forms measured the participants' emotional anxiety, including fear and hyper-arousal, and emotional depressive symptoms, including negative mood, social cognition, and self-perceptions. 24 These scales have been shown to demonstrate sensitivity to change in various populations. 25 Higher score shows higher anxiety or depression. Internal consistency for adolescents is α = 0.85.

| Statistical analyses
Data analyses were performed using SAS 9.4 and Stata 12 Software. Descriptive statistics were used to describe the population, TTC program use, and health-related variable data using means with standard deviation or medians with interquartile range as appropriate. Forty-four participants (50% male) with a mean age of 15.1 years (range=12-17years)participatedinthepilotstudy,withthreeparticipantssubsequentlywithdrawingpost-randomization(totalof19 intervention and 22 control). Six participants in the study group did not complete the interview due to an inability to schedule a time (3) and participants being too busy (3).

| Study population
Four participants (two in the intervention group and two in the control group) enrolled in the study before receiving transplantation.
The two participants in the intervention group were transplanted during their time enrolled in the study. See Table 1 for demographic data and Figure 3 for CONSORT flow diagram.

| Use of the TTC site
Ten participants spent less than 1 hour on TTC in total, and of that group, four participants did not visit the program at any point during the study. Participants who were less than 1-year post-transplant seemed to have longer cumulative program use. See Figure 4 for graphical representation of TTC website use across study time points.

| Preliminary estimates of treatment efficacy
After analyzing results descriptively, the self-management and selfefficacy score interquartile ranges were compared between groups at baseline and 3-month follow-up visits (see Figure 5 for box-plot representation). Table 2 shows mean score comparisons between groups at baseline and 3-month follow-up for medical self-management, generalized self-efficacy, depression, and anxiety scales.
There were no significant differences in scores within or between groups in these or other measures.

| Follow-up interviews
Interviews for the initially recruited participants were conducted 1 to 3 months after completing the study, whereas subsequently recruited participants had greater variation of interview time, with some interviews occurring 3 months post-study completion.
Scheduling difficulties and participant preferences to do the interview in person versus on the phone delayed the timing of the interview. Two participants from the intervention group who did not access the online program at any time declined being interviewed. It was easy to find things that you wanted to look at" (Female,

years old).
A potential barrier to the usability of the intervention included making time to access the website, as explained by participants who stated, "on school days it would be harder to get on because I had my homework to do, but on weekends it was a bit easier" (Female,17yearsold)and,"remindingmyselfwasabigchallenge.
It wasn't super significant, but it was a challenge and reminding myself by putting it into the phone would help me a lot." (Male, 16 years old).
Participants shared suggestions for revising the website which were intertwined with potential barriers involving accessibility, such as one participant who said, "I think you should make it more F I G U R E 3 CONSORT flow chart Excluded (n = 14) • No access to computer (2) • Concerns re time commitment(2) • Lack of interest (10) Lost to follow up F I G U R E 4 Use of TTC program across study time points by the intervention group. A, Study patients who were pretransplant. B, Study patients who were less than 1 y since transplant. C, Study patients who were more than 1 y since transplant. NB Solid line between 0 and 11 min represents three patients who did not spend any time on the website and one patient who spent 5 min and one patient who spent 11 min on the site

| D ISCUSS I ON
This pilot study sought to determine the feasibility, acceptability, and preliminary estimate of impact of the online TTC transplant program using a randomized controlled trial. While there were highaccrual,lowdropoutrates,anda95%rateofoutcomecompletion at baseline and post-study period, there were no significant differences in health outcomes measured between groups.
There was low usage of the online program. Many of the teenagers involved in the study did not utilize the website during the study for the minimum suggested hours even although in the previous study examining usability testing of the website, teenagers gave very positive feedback regarding the website and said they would use it and recommend it to others. 19 In the qualitative interviews and phone check-in with intervention participants, they shared some reasons why they did not utilize the website, including being busy with school work, slow loading pages, and that they could not access the website on their mobile devices. In addition, patients who had received their transplant more than a year previously (and were relatively medically stable) said they were less moti- to improve compliance with the use of online programs. 28,29 In the Teens Take Charge arthritis study, 18 intervention group participants F I G U R E 5 Interquartile ranges for Self-Management Scale and Self-Efficacy Scale outcomes for the intervention and control groups. *Y-axis numbers represent mean raw scores participants. This suggests that combining an eHealth intervention with health professional coaching/peer mentoring allows users to build a relationship and provides a more individually tailored approach to address knowledge gaps and find information that is important and of interest. Thus, utilizing the website within a positive relationship, as a visual tool to reinforce concepts and ideas discussed in one-on-one teaching sessions, may be more effective in this age-group.

| CON CLUS ION
Adolescents in our study expressed finding the website reliable and would recommend it to others; however, this study did not find any differences between the study groups in health outcomes measured. Further research should examine reasons for non-engagement with adolescents in this population and web-based tools. In addition, other methods for improving engagement (such as health coaching, peer mentoring) need to be studied when using the TTC program.
Finally, the value of using TTC as a visual tool during education sessions with adolescents and healthcare professionals could be further examined.

ACK N OWLED G M ENTS
This study would not have been possible without financial support from the Canadian Institutes of Health Research (CIHR); the support of kidney and liver (pre-) transplant patients and their parents who participated in the study; the clinical staff who facilitated recruitment and follow-up; and the group of dedicated professionals who developed content for the website. The research team would also like to acknowledge the help of Derek Stevens, who provided statistical analyses for the project and AboutKidsHealth for their contributions in designing and crafting the online program.