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Systematic Investigation of Blacks With Stroke - GENOMICS (SIBSGENOMICS)

Primary Purpose

Hypertension, Adult, Dyslipidemias

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Riskometer Application
Routine Clinic Therapy
Sponsored by
University College Hospital, Ibadan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Stroke-free adults, Riskometer App, Africans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kwame Nkrumah University of Science and Technology (KNUST)Recruiting
  • Ahmadu Bello University Teaching Hospital, (ABUTH) ZariaRecruiting
  • University College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 24, 2022
Last Updated
November 15, 2022
Sponsor
University College Hospital, Ibadan
Collaborators
Medical University of South Carolina, University of Ibadan, Federal Medical Centre, Abeokuta, Ahmadu Bello University Teaching Hospital, Bayero University Kano, Nigeria, Kwame Nkrumah University of Science and Technology, Korle-Bu Teaching Hospital, Accra, Ghana, University of Alabama at Birmingham, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05619406
Brief Title
Systematic Investigation of Blacks With Stroke - GENOMICS
Acronym
SIBSGENOMICS
Official Title
Systematic Investigation of Blacks With Stroke - GENOMICS (SIBS-GENOMICS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
November 6, 2022 (Actual)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital, Ibadan
Collaborators
Medical University of South Carolina, University of Ibadan, Federal Medical Centre, Abeokuta, Ahmadu Bello University Teaching Hospital, Bayero University Kano, Nigeria, Kwame Nkrumah University of Science and Technology, Korle-Bu Teaching Hospital, Accra, Ghana, University of Alabama at Birmingham, University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Adult, Dyslipidemias, Physical Inactivity, Diabetes, Alcohol Consumption
Keywords
Stroke-free adults, Riskometer App, Africans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The relational data model is adopted in the Model component of the system
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and outcome assessor will be blinded
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Riskometer Application
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Routine Clinic Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome
Description
Total stroke risk probability (0 to 100%) calculated by the software. Reduction in total score of at least 10% over 2 months
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Secondary Outcome
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mayowa O. Owolabi, MD
Phone
+2348020775595
Email
mayowaowolabi@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adekunle G. Fakunle, PhD
Phone
+2348166397832
Email
fakunz@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayowa O. Owolabi, MD
Organizational Affiliation
College of Medicine, University of Ibadan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Ovbiagele, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred S. Sarfo, PhD
Organizational Affiliation
Kwame Nkrumah University of Science & Technology (KNUST)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin S. Aribisala, PhD
Organizational Affiliation
Lagos State University, (LASU)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Nichols, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oyedunni S. Arulogun, PhD
Organizational Affiliation
University of Ibadan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn Jenkins, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bukola Ajala, PhD
Organizational Affiliation
University of Ibadan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Onoja M. Akpa, PhD
Organizational Affiliation
University of Ibadan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Odun J. Akinyemi, PhD
Organizational Affiliation
University of Ibadan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rufus A. Akinyemi, PhD
Organizational Affiliation
University of Ibadan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reginald O. Obiako, PhD
Organizational Affiliation
Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwame Nkrumah University of Science and Technology (KNUST)
City
Kumasi
ZIP/Postal Code
00000
Country
Ghana
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fred S Sarfo, PhD
Email
stephensarfo78@gmail.com
Facility Name
Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria
City
Zaria
State/Province
Kaduna
ZIP/Postal Code
810107
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reginald O Obiako, PhD
Email
orobiako87@gmail.com
Facility Name
University College Hospital
City
Ibadan
State/Province
Oyo
ZIP/Postal Code
20021
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayowa O Owolabi, MD
Phone
+2348020775595
Email
mayowaowolabi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Adekunle G Fakunle, PhD
Phone
+2348166397832
Email
fakunz@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Systematic Investigation of Blacks With Stroke - GENOMICS

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