Systematic Investigation of Blacks With Stroke - GENOMICS
NCT ID: NCT05619406
Last Updated: 2022-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-08-20
2022-12-15
Brief Summary
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Detailed Description
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The burden of stroke on the continent falls heavily on the young productive age group \& is associated with profound diminution in the quality of life via disability, depression, \& vascular cognitive impairment.
World Health Organization estimates that stroke deaths in LMIC account for 86% of stroke deaths worldwide \& disability-adjusted life years lost in LMIC is 7X those lost in high-income countries (HIC). Beyond the personal toll, costs related to stroke are prohibitive and threaten to erode the recent economic gains in Africa where the stroke is a major threat to brain health, brain capital and human capital. The surge in stroke burden in Africa is driven by an unprecedented rise in precursory modifiable cardiometabolic risk factors.
There is an urgent need to deploy evidence-based approaches using the best available context-specific data to surmount the stroke epidemic on the continent by developing population-wide preventive interventions. Achieving this goal requires tackling key barriers to stroke prevention such as lack of awareness and self-directed action to control its risk factors.
Systematic Investigation of Blacks With Stroke (SIBS-GENOMICS) is poised to utilize the best available context-specific data on stroke in Africa to improve, validate, and co-create the first ever Afrocentric stroke riskometer mobile phone application, a self-management tool for stroke prevention. The app, along with a tailored co-created stroke prevention motivational video and educational modules with customized behavioral change activities, will be evaluated for effectiveness to improve individual stroke risk factor awareness and control in the first-of-its-kind randomized control trial (RCT) for a digital tool for primary stroke prevention in Africa.
With the scarcity of acute care and rehabilitation services, coupled with the chronic economic burden imposed by stroke, prevention is evidently the best option towards reducing its burden in Africa. This is concordant with the core mission of the NINDS to reduce the burden of stroke in the USA and globally through translational research and innovation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
The Control Group will be screened at baseline and be informed of their risk factors. They will be counselled to consult their provider following baseline risk factor assessment but this advice will not be reinforced by exposure to the app, stroke video, or module content. At the end of the study (EOS), they will complete a questionnaire to assess possible contamination with the intervention.
Riskometer Application
The intervention group participants at baseline will be assessed by installing a riskometer app on their mobile phones to calculate their global stroke risk score. They will be shown their risk scores and the specific risk factors identified through the screening. They will be counselled and supported to manage their risk factors through lifestyle changes and visit their healthcare provider for appropriate care.
Intervention
The riskometer app will be administered one-on-one to the participants using a smartphone and eventually score and assess them using the global risk score
Routine Clinic Therapy
After their assessment by the blinded adjudicator, the controls will visit the study doctor to obtain the routine clinic therapy and then will be allowed to go home.
Interventions
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Riskometer Application
The intervention group participants at baseline will be assessed by installing a riskometer app on their mobile phones to calculate their global stroke risk score. They will be shown their risk scores and the specific risk factors identified through the screening. They will be counselled and supported to manage their risk factors through lifestyle changes and visit their healthcare provider for appropriate care.
Routine Clinic Therapy
After their assessment by the blinded adjudicator, the controls will visit the study doctor to obtain the routine clinic therapy and then will be allowed to go home.
Eligibility Criteria
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Inclusion Criteria
* age greater than or equal to 18 years.
* with at least 2 stroke risk factors based on the list of 11 top most modifiable risk factors identified in the SIREN study (including hypertension, diabetes mellitus, dyslipidemia, smoking, overweight, physical inactivity, or unbalanced/poor diet).
* ownership or access to smartphones in consenting stroke-free adults.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Medical University of South Carolina
OTHER
University of Ibadan
OTHER
Federal Medical Centre, Abeokuta
UNKNOWN
Ahmadu Bello University Teaching Hospital
OTHER
Bayero University Kano, Nigeria
OTHER
Kwame Nkrumah University of Science and Technology
OTHER
Korle-Bu Teaching Hospital, Accra, Ghana
OTHER
University of Alabama at Birmingham
OTHER
University of Washington
OTHER
University College Hospital, Ibadan
OTHER
Responsible Party
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Mayowa Owolabi
Professor
Principal Investigators
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Mayowa O. Owolabi, MD
Role: PRINCIPAL_INVESTIGATOR
College of Medicine University of Ibadan
Bruce Ovbiagele, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Fred S. Sarfo, PhD
Role: PRINCIPAL_INVESTIGATOR
Kwame Nkrumah University of Science & Technology (KNUST)
Benjamin S. Aribisala, PhD
Role: PRINCIPAL_INVESTIGATOR
Lagos State University, (LASU)
Michelle Nichols, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Oyedunni S. Arulogun, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ibadan
Carolyn Jenkins, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Bukola Ajala, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ibadan
Onoja M. Akpa, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ibadan
Odun J. Akinyemi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ibadan
Rufus A. Akinyemi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ibadan
Reginald O. Obiako, PhD
Role: PRINCIPAL_INVESTIGATOR
Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria
Locations
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Kwame Nkrumah University of Science and Technology (KNUST)
Kumasi, , Ghana
Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria
Zaria, Kaduna State, Nigeria
University College Hospital
Ibadan, Oyo State, Nigeria
Countries
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Central Contacts
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Facility Contacts
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References
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Sarfo FS, Akinyemi JO, Obiako R, Nichols M, Fakunle AG, Adusei N, Ampofo M, Arulogun O, Jenkins C, Akpa OM, Aribisala B, Abdulrasaq S, Akinyemi R, Ovbiagele B, Owolabi MO. Effect of an Educational Intervention for Primary Stroke Risk Reduction in Ghana and Nigeria: Pilot Randomized Controlled Trial. Stroke. 2023 Jun;54(6):1660-1664. doi: 10.1161/STROKEAHA.123.042618. Epub 2023 May 4.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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UI/EC/18/0706
Identifier Type: -
Identifier Source: org_study_id
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