Systematic Investigation of Blacks With Stroke - GENOMICS

Hypertension Clinical Trial

— SIBSGENOMICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619406
• Other study ID #: UI/EC/18/0706
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2022
• Source: University College Hospital, Ibadan
• Contact: Mayowa O. Owolabi, MD
• Phone: +2348020775595
• Email: mayowaowolabi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2022
• Est. primary completion date: November 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult
• Alcohol Consumption
• Alcohol Drinking
• Diabetes
• Dyslipidemias
• Hypertension
• Physical Inactivity

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
Ghana	Kwame Nkrumah University of Science and Technology (KNUST)	Kumasi
Nigeria	University College Hospital	Ibadan	Oyo
Nigeria	Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria	Zaria	Kaduna

Sponsors (10)

Lead Sponsor	Collaborator
University College Hospital, Ibadan	Ahmadu Bello University Teaching Hospital, Bayero University Kano, Nigeria, Federal Medical Centre, Abeokuta, Korle-Bu Teaching Hospital, Accra, Ghana, Kwame Nkrumah University of Science and Technology, Medical University of South Carolina, University of Alabama at Birmingham, University of Ibadan, University of Washington

Countries where clinical trial is conducted

Ghana,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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