Clinical trial NCT02202330: Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors to Improve Outcomes
Official title: Translating Knowledge for Action Against Stroke - Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors and Caregivers to Improve Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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?

Eligibility criteria: 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.

Primary outcomes:
measure: Increase in Adherence and Control of Stroke Risk Factors
timeFrame: 1, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Increase in Knowledge and Decrease in Complications
timeFrame: 1, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University, Clinical Trial Unit
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Dr Ayeesha K Kamal, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
citation: Kamal A, Khoja A, Usmani B, Magsi S, Malani A, Peera Z, Sattar S, Ahmed Akram M, Shahnawaz S, Zulfiqar M, Muqeet A, Zaidi F, Sayani S, Artani A, Azam I, Saleem S. Effect of 5-Minute Movies Shown via a Mobile Phone App on Risk Factors and Mortality After Stroke in a Low- to Middle-Income Country: Randomized Controlled Trial for the Stroke Caregiver Dyad Education Intervention (Movies4Stroke). JMIR Mhealth Uhealth. 2020 Jan 28;8(1):e12113. doi: 10.2196/12113.
citation: Kamal AK, Khoja A, Usmani B, Muqeet A, Zaidi F, Ahmed M, Shakeel S, Soomro N, Gowani A, Asad N, Ahmed A, Sayani S, Azam I, Saleem S. Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke). Trials. 2016 Jan 27;17:52. doi: 10.1186/s13063-016-1175-x.