Systematic Investigation of Blacks With Stroke - GENOMICS

Study Overview
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Brief Summary
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The overall goal of SIBS-GENOMICS is to utilize the best available contextual data on stroke in Africa to develop & validate stroke risk estimation models, translate the best model into a mobile phone app and conduct a randomized control trial of the app with a co-created motivational education video, to determine their effectiveness for improvement of stroke risk factor awareness and global risk reduction among Africans.

Detailed Description
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Africa now bears a foremost burden of stroke worldwide with age standardized stroke incidence rate of up to 316 per 100,000, a prevalence of 1.46 per 1,000 population,1 month fatality of 40% & a 3-year mortality rate of 84%. 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.

Official Title
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Systematic Investigation of Blacks With Stroke - GENOMICS (SIBS-GENOMICS)

Conditions
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Hypertension, Adult, Dyslipidemias, Physical Inactivity, Diabetes, Alcohol Consumption

Intervention / Treatment
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* Device: Riskometer Application
* Behavioral: Routine Clinic Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female (sex is a biologic variable of interest). 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: prior history of vascular disease (e.g., stroke, transient ischemic attack, angina, myocardial infarction, peripheral vascular disease, and atrial fibrillation), or cognitive impairment; not comfortable reading and writing, depression or other psychiatric disorders (through personal declaration) likely to affect the interventions; participation in another RCT; other conditions rendering the individual unsuitable to participate in this research as judged by treating physicians.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The relational data model is adopted in the Model component of the system
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Device: Riskometer Application<br>* 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.<br>|
| Experimental: Intervention<br>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 | Behavioral: Routine Clinic Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | Total stroke risk probability (0 to 100%) calculated by the software. Reduction in total score of at least 10% over 2 months | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome | Stroke risk factors awareness score. List of risk factors will be based on SIREN findings and developed into a questionnaire which will be pretested and validated; and translated/back-translated. Change in individual risk factors will also be assessed and compared. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Riskometer App, Stroke-free adults, Africans