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

NCT ID: NCT02202330

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-06-30

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?

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Standard Care, Organized Discharge

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.

Group Type: PLACEBO_COMPARATOR

Video Arm

Intervention Type: OTHER

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.

Video Arm, Standard Discharge

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.

Group Type: EXPERIMENTAL

Video Arm

Intervention Type: OTHER

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.

Interventions

Video Arm

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ayeesha Kamran Kamal

Associate Professor Neurology,Director Stroke Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Ayeesha K Kamal, MBBS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Aga Khan University, Clinical Trial Unit

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 34813082 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32012080 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26818913 (View on PubMed)

Other Identifiers

URC132001MED

Identifier Type: -

Identifier Source: org_study_id