Title

Does supplementary video based teaching program mild to moderate primary stroke survivors and caregivers change post stroke complications requiring medical attention - a randomized controlled trial

Date of Award

2015

Document Type

Thesis

Degree Name

Master of Science in Epidemiology & Biostatistics (MSc Epidemiology & Biostats)

Department

Community Health Sciences

Abstract

Two-thirds of the global mortality of stroke is borne by low and middle income countries. Pakistan is the world's sixth most populous country with a stroke vulnerable population without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health-care gap, and leveraging the existing greater than 70% mobile phone density, we tested the effectiveness of a mobile phone-based video intervention of short 5 minute movies to educate and support stroke survivors and their primary caregivers. Methods: This was a randomized controlled, outcome assessor blinded, parallel group, single center superiority trial. Participants having an acute stroke, medically stable, with mild to moderate disability and having a stable primary care-giver were included in this trial. After obtaining informed consent, the stroke survivor-caregiver dyads were randomized. Intervention group participants had the movie program software installed in their android device which allowed them to receive, view and repeat five minute videos on stroke related topics at the time of enrollment into the study and at discharge. Control group participants received standard of care at an internationally accredited center with defined protocols. The primary outcome measure, post-stroke complications requiring medical attention was ascertained between the two groups at first month follow-up post-discharge. This trial was designed to enroll 210 participant dyads after increasing to 10% to incorporate attrition and non-compliance. Survival Analysis was used to model poststroke complications against video-based intervention and other covariates. Final analysis was carried out by intention-to-treat (ITT) principle. Results: Two hundred and ten stroke survivors and their caregivers were recruited. Seven participant dyads were lost to follow-up and twelve stroke survivors died during one month follow-up period. After one month post-discharge, stroke survivors having at least one post-stroke complication were 15 in the intervention group as compared to 6 in the control group (p-value 0.05), the adjusted hazard ratio of reporting post-stroke complications in the intervention group was 2.63 (1.17 — 5.93) as compared to control group. Conclusion: This randomized trial tested an application aimed at supporting caregivers and stroke survivors in an LMIC setting with no rehabilitation or chronic support systems. Moreover, in future effectiveness trials are needed to best define pragmatically the roll out of these interventions. Trial Registration: https://clinicaltrials.gov/NCT02202330 (01/28/2015) Key Words: Stroke; Educational Intervention; Behavior Change; Mobile Health; Implementation; Information and Communication Technology, Prevention, Non Communicable Disease, Lower and Middle Income Countries, Adherence.

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