Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 24, 2023
Open Peer Review Period: Jul 24, 2023 - Sep 18, 2023
Date Accepted: Nov 20, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effectiveness of Health Education Program among Stroke Patients and their Caregivers by Controlling Modifiable Risk Factors to Reduce Recurrence of Stroke in a Tertiary Hospital of Bangladesh: Protocol for a Randomized Control Trial
ABSTRACT
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 stroke patients.
Objective:
To evaluate the effectiveness of health education among first-stroke patients and their family caregivers in reducing the recurrence of stroke by controlling modifiable risk factors.
Methods:
It is a parallel, open-label, prospective randomized controlled trial (RCT) conducting at the National Institute of Neuroscience Hospital (NINSH) in Dhaka, Bangladesh. We enrolled stroke patients aged 18 years and above, both sexes and who had history of first-time attack. We stratified the patients with <65 and 65≥ years and types of strokes for randomization. Our estimated sample size was 432. The intervention group is receiving face to face lifestyle modification, blood pressure (BP) monitoring, medication compliance related health education during enrollment and monthly follow up periods. However, the control group is receiving usual care from the hospital. The primary endpoint of this study is to (1) reduce the recurrence rate of stroke at the end of 12 months follow up period. The secondary endpoints are to (1) assess the occurrence of all adverse events, such as other cardiac events and all-cause of mortality, (2) evaluate the status of controlling modifiable risk factors such as of BP, glycated hemoglobin, non- High-Density Lipoprotein cholesterol, (3) asses the knowledge related to stroke by the investigators developed questionnaire, (4) evaluate the lifestyle behavior related to stroke by the investigators developed questionnaire, (5) assess medication adherence, and (6) evaluate the quality of life (QoL) of stroke patients and their family caregivers. The evaluation points will be at baseline, 6 months, and 12 months for both groups.
Results:
Patients’ enrollment was started on October 2022, and follow up will be completed in March 2024. A total of 432 participants were included in both intervention group (n=216) and the control group (n=216).
Conclusions:
Effectiveness of the health education program is expected to be reducing the recurrence of stroke and improving the QoL. The results of this study will provide insights into the importance of health education for (self)-management and prevention of stroke. Clinical Trial: ClinicalTrials.gov NCT05520034; https://clinicaltrials.gov/ct2/show/NCT05520034
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