Back to resultsUsing 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors to Improve Outcomes
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Video Arm
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Aga Khan University, Clinical Trial Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard Care, Organized Discharge
Video Arm, Standard Discharge
Arm 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.
Intervention is as follows: 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) 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. 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.
Outcomes
Primary Outcome Measures
Increase in Adherence and Control of Stroke Risk Factors
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).
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).
Secondary Outcome Measures
Increase in Knowledge and Decrease in Complications
Increase in knowledge of caretakers concerning stroke risk factors, stroke rehabilitation and medications (A knowledge questionnaire will be designed to cover all aspects. This will be administered at 1, 3, 6, 9 and 12 months and improvement in score will be ascertained).
Readmission to hospital with any of the stroke related complications - Urinary Tract infection, pneumonia, Deep vein Thrombosis (This information will be elicited at the follow-up time, based on recall. All subjects will be asked to bring documents related to any hospital admissions in the period following discharge )
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02202330
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care, Organized Discharge
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Video Arm, Standard Discharge
Arm Type
Experimental
Arm Description
Intervention is as follows:
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)
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.
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
Intervention Name(s)
Video Arm
Intervention Description
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)
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.
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.
Primary Outcome Measure Information:
Title
Increase in Adherence and Control of Stroke Risk Factors
Description
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).
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).
Time Frame
1, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Increase in Knowledge and Decrease in Complications
Description
Increase in knowledge of caretakers concerning stroke risk factors, stroke rehabilitation and medications (A knowledge questionnaire will be designed to cover all aspects. This will be administered at 1, 3, 6, 9 and 12 months and improvement in score will be ascertained).
Readmission to hospital with any of the stroke related complications - Urinary Tract infection, pneumonia, Deep vein Thrombosis (This information will be elicited at the follow-up time, based on recall. All subjects will be asked to bring documents related to any hospital admissions in the period following discharge )
Time Frame
1, 3, 6, 9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ayeesha K Kamal, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University, Clinical Trial Unit
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34813082
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.
Results Reference
derived
PubMed Identifier
32012080
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.
Results Reference
derived
PubMed Identifier
26818913
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.
Results Reference
derived
Learn more about this trial
Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors to Improve Outcomes
We'll reach out to this number within 24 hrs