Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-29 @ 4:51 PM
Study NCT ID:
NCT05619406
Status:
UNKNOWN
Last Update Posted:
2022-11-16
First Post:
2022-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Investigation of Blacks With Stroke - GENOMICS
Sponsor:
University College Hospital, Ibadan
Organization:
Study Overview
Official Title:
Systematic Investigation of Blacks With Stroke - GENOMICS (SIBS-GENOMICS)
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIBSGENOMICS
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: