Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors to Improve Outcomes

Aga Khan University

Status: Completed

Conditions: Stroke

Treatments: Other: Video Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT02202330

URC132001MED

Details and patient eligibility

About

Two thirds of all strokes happen in developing countries like Pakistan. There is a serious lack of health literacy regarding survival after stroke. We hypothesize that our set of 5 minute videos that teach important skills to stroke survivors and their caregivers , that can be replayed in cell phones for extended learning, will increase their adherence to Medications after stroke and improve the control of blood pressure, elevated cholesterol and glucose in the participants getting cell phone based educational videos.

Full description

In 80% of patients with stroke, further events may be prevented by altering lifestyle behavioral risk, and increasing adherence to medications to control hypertension, diabetes, lipids. Yet, there exists a huge science to implementation gap to adopt these widely recognized beneficial medicines and lifestyle changes. Those most in need remain unable to actualize the benefits of science, due to lack of knowledge, perceived complexity, literacy challenges, limited time by poorly communicating doctors in crowded clinics and essentially, failure by regional scientists to translate Western science in creative resonant ways that enable wider uptake.

In this randomized double blind translational implementation study, we will study the effectiveness of the implementation tactic of delivering enabling stroke education and risk reduction to literacy and numeracy challenged Pakistani stroke survivors and their caregivers, via short films teaching stroke recognition, healthy habits, medication adherence and self-care. These 5 minute films , using a 'show me not tell me ' approach, will be replayed in tablets, and shown to all stroke patients in the intervention arm. The primary objective of this study is to answer the research question - Does video based education given to stroke patients (with mild to moderate disability) and their caregivers before discharge, and during follow up, improve adherence to therapy and control of three major risk factors (Diabetes, hypertension and dyslipidemia) at twelve months post index stroke?

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult men and women, > 18 years of age
2. Resident of Karachi and planning to live in Karachi to complete long term follow up
3. Able to understand Urdu (language of the videos)
4. Admitted with first ever stroke (ischemic or hemorrhagic)
5. Modified Rankin score <3 ( Mild strokes)
6. Have at least one vascular risk factor that requires medical intervention
7. Consent to participate in the study and follow up, both stroke and caregiver.
8. Have a stable surrogate caregiver at home who is responsible for appointments, follow-ups, overall care, e.g., wife, daughters, daughter- in- law, etc.

Exclusion criteria

1. Serious aphasia, visual hemi neglect, short term memory loss in the patient precluding understanding, visualization or retention of the video material, despite overall "a small stroke", this would be a cognitively critical stroke.
2. Serious aphasia, visual hemi neglect, short term memory loss, dementia in the caregiver precluding understanding, visualization or retention of the video material.
3. Iatrogenic stroke, stroke due to non-atherosclerotic vascular disease and rare causes e.g. moya moya, carotid dissections, gunshot to neck, post Coronary Artery Bypass surgery etc.
4. Serious concurrent medical illnesses, like cancer, renal failure, acute liver disease in past 6 months (that precludes use of statins), chronic liver disease, that exclude the use of stroke preventive medications, or require non standardized therapy.
5. Any use of off label, non-guideline medications, due to patient unique comorbid conditions that interfere with medication compliance to antihypertensive, statins, antiplatelet agents and diabetes control.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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310 participants in 2 patient groups, including a placebo group

Standard Care, Organized Discharge

Placebo Comparator group

Description:

Stroke patients are given instructions before discharge regarding diet, need for rehabilitation, possible complications, medication use and information booklets are also handed out. This information is imparted by a multidisciplinary team consisting of a neuro physician, a stroke nurse, a dietitian and a physiotherapist. These are verbal instructions and handouts are written in English. On the day of discharge, or 24 hours prior to discharge, a discharge coordinator details the skills learnt . A detailed written discharge summary is given out detailing all aspects of care, follow-up, medications and test results.

Treatment:

Other: Video Arm

Video Arm, Standard Discharge

Experimental group

Description:

Intervention is as follows: 1. 5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made) 2. Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video. 3. Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions.

Treatment:

Other: Video Arm