HypertensionSIBSGENOMICSNCT05619406
Systematic Investigation of Blacks With Stroke - GENOMICS
A study testing Riskometer Application and Routine Clinic Therapy in people with Hypertension and Adult, run by University College Hospital, Ibadan at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Adult, Dyslipidemias
- What is being tested?
- Riskometer Application and Routine Clinic Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 20 Aug 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Nigeria2 sites, 2 recruiting
- Recruiting
University College Hospital
Ibadan, Oyo State, 20021
Mayowa O Owolabi, MD, +2348020775595, mayowaowolabi@yahoo.com
Adekunle G Fakunle, PhD, +2348166397832, fakunz@yahoo.com
- Recruiting
Ahmadu Bello University Teaching Hospital, (ABUTH) Zaria
Zaria, Kaduna State, 810107
Reginald O Obiako, PhD, orobiako87@gmail.com
Ghana1 site, 1 recruiting
- Recruiting
Kwame Nkrumah University of Science and Technology (KNUST)
Kumasi, 00000
Fred S Sarfo, PhD, stephensarfo78@gmail.com
About this study
Official title: Systematic Investigation of Blacks With Stroke - GENOMICS (SIBS-GENOMICS)
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.
Read the 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
- Being tested
- Riskometer Application, Routine Clinic Therapy
- Keywords
- Stroke-free adults, Riskometer App, Africans
- Medical subject headings
- Hypertension, Dyslipidemias, Sedentary Behavior, Diabetes Mellitus, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Routine Clinic TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Routine Clinic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Total stroke risk probability (0 to 100%) calculated by the software. Reduction in total score of at least 10% over 2 months
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start20 Aug 2022
- Primary completion6 Nov 2022
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The relational data model is adopted in the Model component of the system
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital, Ibadan
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Mayowa Owolabi, University College Hospital, Ibadan
- Investigators
- Mayowa O. Owolabi, MD, Principal investigator, College of Medicine University of IbadanBruce Ovbiagele, MD, Principal investigator, University of California, San FranciscoFred S. Sarfo, PhD, Principal investigator, Kwame Nkrumah University of Science & Technology (KNUST)Benjamin S. Aribisala, PhD, Principal investigator, Lagos State University, (LASU)Michelle Nichols, PhD, Principal investigator, Medical University of South CarolinaOyedunni S. Arulogun, PhD, Principal investigator, University of IbadanCarolyn Jenkins, PhD, Principal investigator, Medical University of South CarolinaBukola Ajala, PhD, Principal investigator, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619406
- Sponsor's protocol ID
- UI/EC/18/0706
- Acronym
- SIBSGENOMICS
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37139815
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Investigation of Blacks With Stroke - GENOMICS (SIBS-GENOMICS)
- ClinicalTrials.gov ID
- NCT05619406
- Acronym / sponsor ID
- SIBSGENOMICS / UI/EC/18/0706
- Conditions
- Hypertension, Adult, Dyslipidemias, Physical Inactivity, Diabetes, Alcohol Consumption
- Keywords
- Stroke-free adults, Riskometer App, Africans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College Hospital, IbadanUniversity, hospital or other
- 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
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The relational data model is adopted in the Model component of the system
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Riskometer ApplicationThe 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. |
| Intervention | Experimental | Behavioral: Routine Clinic TherapyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riskometer ApplicationThe 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. | Device | Control |
| Routine Clinic TherapyAfter 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. | Behavioural | Intervention |
Primary outcome
Primary Outcome
Time frame: 2 months
Total stroke risk probability (0 to 100%) calculated by the software. Reduction in total score of at least 10% over 2 months
1 secondary outcome
Secondary Outcome
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 37139815Sarfo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayowa O. Owolabi, MD principal investigator
College of Medicine University of Ibadan
Bruce Ovbiagele, MD principal investigator
University of California, San Francisco
Fred S. Sarfo, PhD principal investigator
Kwame Nkrumah University of Science & Technology (KNUST)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riskometer Application and Routine Clinic Therapy in people with Hypertension and Adult, run by University College Hospital, Ibadan at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria, Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayowa O. Owolabi, MD (+2348020775595, mayowaowolabi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.