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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 August 2016 |
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Main ID: |
NCT02202330 |
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Date of registration:
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24/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors to Improve Outcomes
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Scientific title:
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Translating Knowledge for Action Against Stroke - Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors and Caregivers to Improve Outcomes |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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310 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02202330 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Dr Ayeesha K Kamal, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aga Khan University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Other: Video Arm
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Primary Outcome(s)
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Increase in Adherence and Control of Stroke Risk Factors
[Time Frame: 1, 3, 6, 9 and 12 months]
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Secondary Outcome(s)
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Increase in Knowledge and Decrease in Complications
[Time Frame: 1, 3, 6, 9 and 12 months]
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Secondary ID(s)
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URC132001MED
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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