Effectiveness of a Health Education Program for Patients Who Had a Stroke and Their Caregivers by Controlling Modifiable Risk Factors to Reduce Stroke Recurrence in a Tertiary Hospital in Bangladesh: Protocol for a Randomized Controlled Trial
Authors: Afrin Mahabuba , Khan Sharif Uddin , Das Subir Chandra , Huq K A T M Ehsanul , Moriyama Michiko 
Published: November 2023

Background
Stroke is a significant public health concern that causes severe and long-lasting disability. The recurrence of stroke is increasing due to lack of patients’ knowledge and compliance with treatment to control modifiable risk factors and lifestyle changes. Health education can be an effective way to increase knowledge about behavioral changes in patients who had a stroke.

Objective
The aim of this study is to evaluate the effectiveness of a health education program in Bangladesh for patients who had their first stroke and their family caregivers in order to reduce the recurrence of stroke by controlling modifiable risk factors.

Methods
This is a parallel, open-label, prospective randomized controlled trial conducted at the National Institute of Neurosciences & Hospital in Dhaka, Bangladesh. We enrolled ≥18-year-old patients of both sexes who had a history of first stroke attack (transient ischemic attack, hemorrhagic stroke, lacunar stroke, atherothrombotic stroke, or cardioembolic stroke). We stratified patients into those aged <65 years and those aged ≥65 years and according to types of strokes for randomization. Our estimated sample size was 432. The intervention group receives face-to-face counseling on lifestyle modifications, blood pressure monitoring, and medication compliance–related health education during enrollment and monthly follow-ups. However, the control group receives only usual care from the hospital. The primary end point of this study is the reduction in the stroke recurrence rates at the end of the 12-month follow-up period. The secondary end points are to (1) assess the occurrence of all adverse events such as other cardiac events and all-cause mortality, (2) evaluate the status of the controlling modifiable risk factors such as blood pressure, glycated hemoglobin, and non–high-density lipoprotein cholesterol, (3) assess the knowledge related to stroke by using the investigator-developed questionnaire, (4) evaluate the lifestyle behavior related to stroke by using the investigator-developed questionnaire, (5) assess medication adherence, and (6) evaluate the quality of life of patients who had a stroke and their family caregivers. The evaluation points will be at baseline, 6 months, and 12 months for both groups.

Results
Patients’ enrollment started on October 2022, and follow-up will be completed in March 2024. A total of 432 participants were included in both the intervention (n=216) and control groups (n=216). This study was approved by the institutional review board and the ethics review board of the National Institute of Neurosciences & Hospital (IRB/NINSH/2022/151) on August 30, 2022.

Conclusions
Our health education program is expected to reduce the recurrence of stroke and improve the quality of life of patients who have had the first stroke. The results of this study will provide insights into the importance of health education for (self)-management and prevention of stroke.

Trial Registration
ClinicalTrials.gov NCT05520034; https://clinicaltrials.gov/ct2/show/NCT05520034

International Registered Report Identifier (IRRID)
DERR1-10.2196/51178