Clinical trial NCT05619406: Systematic Investigation of Blacks With Stroke - GENOMICS
Official title: Systematic Investigation of Blacks With Stroke - GENOMICS (SIBS-GENOMICS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Adult
Dyslipidemias
Physical Inactivity
Diabetes
Alcohol Consumption
Keywords: Stroke-free adults
Riskometer App
Africans
Lead sponsor: University College Hospital, Ibadan
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: University of Ibadan
name: Federal Medical Centre, Abeokuta
name: Ahmadu Bello University Teaching Hospital
name: Bayero University Kano, Nigeria
name: Kwame Nkrumah University of Science and Technology
name: Korle-Bu Teaching Hospital, Accra, Ghana
name: University of Alabama at Birmingham
name: University of Washington
First posted: 2022-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The relational data model is adopted in the Model component of the system
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome
timeFrame: 2 months
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 2 months
Other outcomes:
Locations:
city: Kumasi
country: Ghana
facility: Kwame Nkrumah University of Science and Technology (KNUST)
city: Zaria
country: Nigeria
facility: Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria
state: Kaduna
city: Ibadan
country: Nigeria
facility: University College Hospital
state: Oyo
Study officials:
affiliation: College of Medicine University of Ibadan
name: Mayowa O. Owolabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Bruce Ovbiagele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwame Nkrumah University of Science & Technology (KNUST)
name: Fred S. Sarfo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lagos State University, (LASU)
name: Benjamin S. Aribisala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Michelle Nichols, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: Oyedunni S. Arulogun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Carolyn Jenkins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: Bukola Ajala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: Onoja M. Akpa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: Odun J. Akinyemi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: Rufus A. Akinyemi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria
name: Reginald O. Obiako, PhD
role: PRINCIPAL_INVESTIGATOR
References: