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

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ClinicalTrials.gov Identifier: NCT02202330
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ayeesha Kamran Kamal, Aga Khan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Other: Video Arm Not Applicable

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?

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 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.
 Other: 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.
Experimental: 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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Increase in Adherence and Control of Stroke Risk Factors [ Time Frame: 1, 3, 6, 9 and 12 months ]
    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).


Secondary Outcome Measures :
  1. Increase in Knowledge and Decrease in Complications [ Time Frame: 1, 3, 6, 9 and 12 months ]
    1. 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).
    2. 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 )


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202330


Locations
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Pakistan
Aga Khan University, Clinical Trial Unit
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Dr Ayeesha K Kamal, MBBS Aga Khan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Ayeesha Kamran Kamal, Associate Professor Neurology,Director Stroke Services, Aga Khan University
ClinicalTrials.gov Identifier: NCT02202330    
Other Study ID Numbers: URC132001MED
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases