An assessment of quality of life among stroke survivors at tertiary care teaching hospital in South India: A randomized clinical trial

The study's primary aim was to examine how a stroke affects health‐related quality of life (QoL), and a secondary aim was to link this event with clinical and sociodemographic factors. Stroke patients were included in the study. First, 94 patients underwent a quantitative analytical cross‐sectional study 3 months after starting medication. Using multivariable linear regression, relationships between the severity of the initial stroke were investigated. From the raw data, we determined the standard deviation and the standard error of the mean. If the p‐value is less than .05, it is considered significant, and if it's less than .0001, it is extremely significant. The majority 94.68% were diagnosed with ischemic stroke, and only 5.32% were hemorrhagic stroke; 56.32% of the patients were male, and 43.68% were female; one‐third of the patients were found to be smokers and alcoholics; 9.57% of the patients had a family history of stroke; and 9.5% of the patients had a history of stroke. Patients with stroke comorbidities, including high blood pressure 88.19%, diabetes 51.06%, high cholesterol 22.34%, coronary artery disease 23.40%, smoking 30.85%, and alcoholism 24.46%. Significant dangers were posed by both hypertension and smoking. There was a statistically significant improvement in quality of life between the two groups, with the intervention group showing a mean difference of 112. The p‐value for this improvement was less than .0001. The quality of life of stroke survivors can be improved through direct screening, monitoring of the patient, planned therapy, and management.


| INTRODUCTION
Stroke is becoming as a major cause of mortality and disability among the poor. This rising mortality rate is mostly attributable to modifiable risk factors. [1][2][3] Due to the country's massive population and the prohibitive cost of stroke treatment, this mortality rate disproportionately affects India's poor. World Health Organization (WHO) data from 2001 show that South Asian developing nations accounted for 56% of all stroke-related deaths. [4][5][6] Ischemic stroke accounts for about 85% of all strokes, while hemorrhagic strokes account for the remaining 15%. The data also suggests that small artery disease and embolism account for 50% of strokes, while large vessel disease accounts for the remaining 50%. 7 Mortality from stroke is more common among older men than among women of the same age, and this differ- shifts for stroke survivors as they learn to live again. Because of this, HRQoL has been one of the input criteria used to evaluate recovery after stroke. [9][10][11] Physical, mental, functional, and social dimensions all play a role in how HRQoL is assessed. It's important to separate out how survivors' HRQoL in a given dimension changes over time. In spite of the fact that data on the monetary cost of stroke and its determinants on long-term survivors' HRQoL had already been generated in a developed country, studies have been carried out in the latter. 12,13 Rapid onset of a targeted deficit in brain function; typically hemiplegic but may also include focal higher cerebral dysfunction, hemisensory loss, visual field defect, or brain stem deficit; this is the hallmark of an acute stroke. Stroke can be classified into two main types: ischemic and hemorrhagic. 14 The American Heart Association (AHA) said in 2009 that 87% of strokes are caused by clots or thrombosis and 13% by bleeding. Stroke is largely influenced by a wide range of factors, including but not limited to: high blood pressure, high blood cholesterol, age, gender, genetics and race, diabetes mellitus, physical inactivity, obesity, cardiovascular disease, drug misuse, and so on. These danger elements are generally split between those that can be changed and those that cannot. Modifiable, well-documented risk factors are the primary focus of recommendations for risk factor reduction, however patients with non-modifiable risk factors are also given consideration. 15 Symptoms of transient ischemic attack can be treated if the underlying causes are determined. This requires an accurate diagnosis based on a patient's medical history and a thorough physical examination. Treatment results in less neuronal injury, death, and long-term durability; it also helps prevent consequences from immobilization, neurological dysfunction, and recurrence. 16 The effectiveness of stroke therapies has typically been evaluated by looking at patients' quality of life. A higher quality of life may be associated with the stroke survivor's increased awareness of stroke risk that can be reported after this evaluation. Both generic and stroke-specific tools are available for assessing a stroke patient's quality of life. 17 Examining and contrasting the HRQoL of various individuals requires the use of generic instruments, which allow for the investigation of health issues of universal interest. The current study's objectives are to analyze the effects of hospitalized stroke patients' medication regimens on their quality of life and assess the effectiveness of these regimens.

| Study design
Stroke survivors were the units of randomization in a 12-month-long clinical experiment. Patients who presented with a diagnosis of stroke to the neurology, cardiology, or general medicine departments were prospectively included. Participants in the study lived at least 3 months after suffering a stroke. Stroke was clinically defined using a brain CT scan; however, in areas where this was unavailable, as is the case in most low-income countries, diagnoses were made using the world health organization's clinical criteria. Patients in critical care, those unable to converse fluently, and those without close, suitable, and dependable proxies were not included in the study.
Before taking part in the study, every individual gave their written informed consent. The study's goals and methods were outlined to participants in their first language. Respondents were made aware that their reluctance to take part in the survey would not affect the quality of care they received. The study followed the ethical guidelines outlined in the declaration of Helsinki. 18,19 The institution's ethics committee granted their permission on February 10, 2022 (SJPCEC/P25/PP/2022/020).

| Sample size
The 94 patients were initially enrolled in this trial where the standard normal variate is 1.96 and at 1% type 1 error P < .01 it is 2.46. P-value <.05 is considered significant. Among 94 patients, only 78 were recruited from the inclusion criteria. From these 78 patients, 38 patients were assigned to the control group and 40 patients were assigned to the interventional group based on stratified random allocation technique Figure 1.

| Study selection process
Following a baseline evaluation, participants were randomly assigned to either the intervention or control groups. [20][21][22] Before taking part in the study, participants completed a consent form acknowledging that they had been briefed about the study's purpose and procedures. The interventional group received pharmacist intervention, patient counseling, and patient education leaflets in addition to the general care.

| Data collection
Inclusion and exclusion criteria were used for the primary screening.
At the beginning of patient recruitment, a number of baseline variables should be recorded. Patients' names, ages, sexes, medical histories such as whether or not they have a family history of stroke and the type of stroke suffered, current medical histories such as the results of any recent surgeries, laboratory and scan findings, hospital identification numbers, and so forth. The questionnaire was designed using the World Health Organization's conceptual framework for an all-encompassing assessment of QoL. [23][24][25] Participants in the study were split at random into a control group and an experimental group. In the treatment group, patients got standard medical attention from doctors and nurses. The intervention group received assistance from a chemist, as well as counseling and educational pamphlets. At the time of the subsequent visit, both groups were engaged in follow-up.

| Inclusion criteria
• Stroke with a single lesion that affects only one side of the brain (temporal, frontal, parietal, or subcortical).
• Experience a significant stroke incident.
• Residual function of the affected extremity.
• Both sexes above the age of 18 years. 26

| Exclusion criteria
• Patients who are younger than 18 years old.
• The presence of two or more serious mental or physical illnesses at the same time.
• Patients who were not willing to participate in the study.
• Severe language or cognitive impairment.

| Statistical analysis
Graphpad Prism version 6.0 was used for the statistical analysis. 27 For the SF-36 Health Survey, we averaged each patient's score across the eight subscales to arrive at an overall quality of life rating. From the raw data, we determined the standard deviation and the standard error of the mean. A p-value of less than .05 is deemed significant at the 95% level of significance, while a p-value of less than .0001 is considered extremely significant.

| RESULTS
There was a significant cluster of responders ages between 70 and 79.  Figure 2.
Baseline and follow-up systolic and diastolic blood pressure in the control group were 142/95 mm Hg (baseline) and 135/85 mm Hg (follow-up) respectively, during this investigation. And blood pressure was 147/90 mm Hg (baseline) and 120/80 mm Hg (follow-up) in the intervention group, respectively. Table 2 the p-value for comparing systolic and diastolic blood pressures between the control and intervention groups is incredibly low, indicating that the systolic blood pressure in the intervention group is much lower than that in the control group. Both the control group's fasting blood glucose 127 mg/dL and the intervention group's 112 mg/dL show decreased levels comparatively higher reduction in the intervention group. Table 2 Table 3 for both the control and intervention groups in this study. Table 4

| DISCUSSION
This study, to the best of our knowledge, provides essential information for gauging the impact of stroke on the quality of life of survivors.
Previous research has shown that stroke not only leads to mortality and disability but also significantly lowers quality of life. [28][29][30][31] Researchers have found that patients' QOL can decrease due to the presence of chronic conditions like viral infections, metabolic disorders, and cardiovascular disease. 32 The study includes measurements of a wide range of HRQoL, including general health, pain, social health, emotional well-being, energy, and physical function.
Initially, 94 potential study participants were randomly split into two groups, one receiving no treatment and the other receiving treat- T A B L E 1 Demographic characteristics of study subjects. antiplatelet medications like aspirin and clopidogrel, as well as neuroprotective medicines like mannitol and citicoline. 19 Additional stroke risk reduction was achieved with the use of anti-hypertensive, hypoglycemic, and cholesterol-lowering medication. 20 Both two groups, patients quality of life was not satisfactory at the initial interview. 17 The patients in the study's control group receive just medical and nursing attention from the study's researchers, while those in the intervention group receive the same medical and nursing attention from the study's researchers as well as pharmaceutical treatment from a clinical pharmacist. 33,34 Statistical analysis reveals that both groups' quality of life enhanced after the intervention, but the p-value indicates that the intervention group's improvement was more substantial. 24

| CONCLUSION
In summary, QOL trajectories were substantially linked with age and gender in this study, with better long-term outcomes for women and younger stroke survivors compared to males and those of older ages.

ACKNOWLEDGMENTS
The authors thank the faculty, residents, physiotherapists, and staff of the Department of Geriatric Medicine for their assistance with data collecting.

CONFLICT OF INTEREST STATEMENT
The authors declare no conflicts of interest.
T A B L E 3 Quality of Life (QoL) score for individual domains with control and intervention group.