JMIR Publications

ABSTRACT

Background:

Pakistan is the sixth most populous nation in the world, and has an estimated 4 million stroke survivors. Most survivors are taken care of by caregivers and there are no inpatient rehabilitation facilities. This study tested the effectiveness of a customized mHealth software program that showed short 5-minute movies on post-stroke survival, medication adherence, response to emergencies, home-based rehabilitation and dysphagia exercises, and boosted the knowledge and medical skills of the survivor – caregiver dyad. Pakistan has 92% internet coverage and 77% mobile phone users; we installed these movies in smart phones and allowed a planned and thematic access to the movies during the progress of the trial. We rationalized that repeated high quality audio and visual education with competency checks will improve post-stroke outcomes.

Objective:

This study tested the effectiveness of a customized mHealth software program that showed short 5-minute movies on post-stroke survival, medication adherence, response to emergencies, home-based rehabilitation and dysphagia exercises, and boosted the knowledge and medical skills of the survivor – caregiver dyad. Pakistan has 92% internet coverage and 77% mobile phone users; we installed these movies in smart phones and allowed a planned and thematic access to the movies during the progress of the trial. We rationalized that repeated high quality audio and visual education with competency checks will improve post-stroke outcomes.

Methods:

A randomized controlled, outcome assessor blinded, parallel group, single center superiority trial in which participants (stroke survivor – caregiver dyads) with first ever stroke (both ischemic and hemorrhagic) were randomized within 48 hours of their stroke to either the video-based education intervention group or the control group. The video-based education intervention group had health education delivered through short videos that focused on a skill relevant to stroke that was shown to the participants and their caregivers at the time of admission, before discharge, at follow-up at first and third month post discharge. The control group had standardized care including pre-discharge education and counseling according to defined protocols of the center. A stroke survivor was defined as any adult aged 18 years of age or older, having experienced first ever stroke (ischemic or hemorrhagic) within the past 6 weeks, with mild to moderate disability, moreover, stroke is clinically stable and the stroke survivor is returning to the community for chronic care. Caregiver was defined as an adult aged 18 years of age or older who is present 24 hours a day with the stroke survivor and provides the overall day-to-day care of the stroke survivor. All participants enrolled in this video education intervention group and control group were followed for 12 months post discharge for the assessment of outcomes in the outpatient stroke clinics. The primary outcome measures were the proportion of participants adhering to medications prescribed measured by the self-reported and validated Urdu Morisky Medication Adherence Scale (MMAS) and the proportion of participants achieving control of blood pressure (control was defined as BP <125/85), blood sugar (glycosylated hemoglobin (HbA1c) <7 %) and blood cholesterol (low-density lipoprotein cholesterol (LDL) <100 mg/dl) in the video group vs. the control group. A number of predefined secondary outcomes were included in this study; we report here mortality and functional disability at 12 months. Both primary and secondary outcomes were ascertained through blinded outcomes assessment by trained health professionals and analysis was by intention-to-treat.

Results:

Three hundred and ten stroke survivors and their caregiver dyads (participant dyads) were recruited over a duration of six months. We screened 400 participant dyads to assess eligibility, of these 50 were not eligible and 40 participant dyads refused to participate in the study. One hundred and fifty-five participant dyads were randomized in the intervention group and control group respectively. At baseline, variables were uniformly distributed between the two groups and were not statistically significant. Self-reported Medication Adherence by the Urdu MMAS had a greater percentage of participants in the intervention group reporting high adherence as compared to the control group (74.4% vs. 69.7%, 77.9% vs. 69.6%) at sixth and twelfth month respectively. The primary outcome of control of three major risk factors revealed that, at 12 months, there was a greater percentage of participants in the intervention group as compared to the control group, having systolic blood pressure of <125 mmHg, diastolic blood pressure of <85 mmHg, HbA1c of <7 %, LDL of <100 mg/dl (62% vs. 38%, 55% vs. 45%, 55% vs. 45%, 55% vs. 45%) respectively. However, none of these results were statistically significant. The secondary outcome reported is the disability of the stroke survivors as assessed through mRs, NIHSS and Barthel Index which demonstrated a greater percentage in the intervention group as compared to the control group at the end of twelve months of those survivors having minimal to no disability, minimal neurologic deficit and minimal to no dependency as assessed by three functional scales (71.1 % vs. 59.2%, 50.8% vs. 45.8%, 68.0% vs. 59.2%). Mortality among stroke survivors due to stroke related complications was higher in the control group as compared to intervention group (13 vs. 2) and it was statistically significant as well (p-value <0.01).

Conclusions:

The Movies4Stroke trial failed to achieve its primary specified outcomes. There were no significant differences in either medication adherence or control of three stroke risk factors; blood pressure, glucose or cholesterol. However, secondary outcomes that directly related to survival skills of stroke survivors demonstrated the effectiveness of video based intervention on improving stroke related mortality and survival without disability. The intervention appeared feasible and safe, despite its complexity and the lack of literacy skills in this setting. Complex interventions targeting these settings need to have a design theory in place to deliver both the compliance and the knowledge transfer and the skills to be effective. Clinical Trial: NCT02202330 (28 January 2015)