NCT05619406

Systematic Investigation of Blacks With Stroke - GENOMICS

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University College Hospital, Ibadan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-20
• Primary completion: 2022-11-06
• Completion: 2022-12-15
• First posted: 2022-11-16
• Last updated: 2022-11-16

Locations

3 sites across 2 countries: Ghana, Nigeria