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

NCT02202330 | Completed DMC

• 1 other identifier: URC132001MED
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Increase in Adherence and Control of Stroke Risk Factors

  1. Proportion of participants adhering to medications prescribed (Definition of adherence- use of prescribed medications on \>5 days a week and measured by the Morisky adherence scale(18). 2. Proportion of participants achieving control of blood pressure (control is defined as BP\<125/85), blood sugar (HbA1c\<7) and blood cholesterol (LDL \< 100)(19).

  1, 3, 6, 9 and 12 months

Secondary Outcomes (1)

• Increase in Knowledge and Decrease in Complications

  1, 3, 6, 9 and 12 months

Study Arms (2)

Standard Care, Organized Discharge

PLACEBO COMPARATOR

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.

Other: Video Arm

Video Arm, Standard Discharge

EXPERIMENTAL

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.

Other: Video Arm

Interventions

Video Arm 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.

Standard Care, Organized Discharge; Video Arm, Standard Discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Serious aphasia, visual hemi neglect, short term memory loss, dementia in the caregiver precluding understanding, visualization or retention of the video material.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University, Clinical Trial Unit

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 34813082 DERIVED

• 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.

  PMID: 32012080 DERIVED

• 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.

  PMID: 26818913 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr Ayeesha K Kamal, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Neurology,Director Stroke Services

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 29, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

PA (1)