NCT05619406

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

October 24, 2022

Last Update Submit

November 15, 2022

Conditions

HypertensionAdultDyslipidemiasPhysical InactivityDiabetesAlcohol Consumption

Keywords

Stroke-free adultsRiskometer AppAfricans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary Outcome

    2 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Intervention

EXPERIMENTAL

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

Interventions

Riskometer ApplicationDEVICE

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.

Control
Routine Clinic TherapyBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kwame Nkrumah University of Science and Technology (KNUST)

Kumasi, 00000, Ghana

RECRUITING

Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria

Zaria, Kaduna State, 810107, Nigeria

RECRUITING

University College Hospital

Ibadan, Oyo State, 20021, Nigeria

RECRUITING

Related Publications (1)

  • Sarfo FS, Akinyemi JO, Obiako R, Nichols M, Fakunle AG, Adusei N, Ampofo M, Arulogun O, Jenkins C, Akpa OM, Aribisala B, Abdulrasaq S, Akinyemi R, Ovbiagele B, Owolabi MO. Effect of an Educational Intervention for Primary Stroke Risk Reduction in Ghana and Nigeria: Pilot Randomized Controlled Trial. Stroke. 2023 Jun;54(6):1660-1664. doi: 10.1161/STROKEAHA.123.042618. Epub 2023 May 4.

    PMID: 37139815DERIVED

MeSH Terms

Conditions

HypertensionDyslipidemiasSedentary BehaviorDiabetes MellitusAlcohol Drinking

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorGlucose Metabolism DisordersEndocrine System DiseasesDrinking Behavior

Study Officials

  • Mayowa O. Owolabi, MD

    College of Medicine University of Ibadan

    PRINCIPAL INVESTIGATOR

  • Bruce Ovbiagele, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Fred S. Sarfo, PhD

    Kwame Nkrumah University of Science & Technology (KNUST)

    PRINCIPAL INVESTIGATOR

  • Benjamin S. Aribisala, PhD

    Lagos State University, (LASU)

    PRINCIPAL INVESTIGATOR

  • Michelle Nichols, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Oyedunni S. Arulogun, PhD

    University of Ibadan

    PRINCIPAL INVESTIGATOR

  • Carolyn Jenkins, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Bukola Ajala, PhD

    University of Ibadan

    PRINCIPAL INVESTIGATOR

  • Onoja M. Akpa, PhD

    University of Ibadan

    PRINCIPAL INVESTIGATOR

  • Odun J. Akinyemi, PhD

    University of Ibadan

    PRINCIPAL INVESTIGATOR

  • Rufus A. Akinyemi, PhD

    University of Ibadan

    PRINCIPAL INVESTIGATOR

  • Reginald O. Obiako, PhD

    Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayowa O. Owolabi, MD

CONTACT

+2348020775595mayowaowolabi@yahoo.com

Adekunle G. Fakunle, PhD

CONTACT

+2348166397832fakunz@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator and outcome assessor will be blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The relational data model is adopted in the Model component of the system
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 24, 2022

First Posted

November 16, 2022

Study Start

August 20, 2022

Primary Completion

November 6, 2022

Study Completion

December 15, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

NG(2)GH(1)