Status:
COMPLETED
A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk Ugandans
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Fogarty International Center of the National Institute of Health
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed 2-phase project will first refine the TargetEd MAnageMent (TEAM) intervention to ensure acceptability across a broad range of Ugandans at risk for stroke and then test the effects of TEAM...
Detailed Description
In Phase 1 of the project, stakeholder's advisory board (SAB) will be convened across 3 Ugandan sites. The SAB will be composed of up to 15 relevant stakeholders including 3 stroke survivors, 3 indivi...
Eligibility Criteria
Inclusion
- Age range: ≥ 18 years
- At risk for stroke defined by the following:
- High systolic BP defined as ≥ 140 mmHg assessed on at least 2 occasions at least 3 days apart and either criterion b or c as noted below:
- At least 1 other modifiable stroke risk factor including: diabetes, hyperlipidemia, obesity, smoking, problem alcohol use or sedentary lifestyle. Problem alcohol use for screening purposes will be assessed with questions on frequency, type of alcohol and quantity consumed. Participants will be classified as engaging in potential problem alcohol use if they exceed the recommended level for safe alcohol intake i.e. more than 3 drinks on average every time they drink, or if they undertook binge drinking (i.e. more than 3 drinks on one occasion in the one month preceding the evaluation).
- History of stroke or transient ischemic attack within the past 5 years
- Able to participate in group sessions
Exclusion
- Individuals who are unable or unwilling to provide written informed consent
- Individuals who have sickle-cell disease
- Females who are pregnant or lactating
- Individuals with dementia
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT04685408
Start Date
May 13 2022
End Date
September 3 2024
Last Update
August 3 2025
Active Locations (3)
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1
Mulago Hospital
Kampala, Uganda
2
Nsambya Hospital
Kampala, Uganda
3
Mbarara Regional Referral Hospital
Mbarara, Uganda