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Completed
NCT04685408
A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk Ugandans
Conditions: Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 276
Sponsor: Case Western Reserve University
Location: Mulago Hospital Kampala
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 in reducing stroke risk in a 3-site, prospective, 6-month randomized controlled trial (RCT).
Eligibility Criteria
Inclusion Criteria:
* Age range: ≥ 18 years
* At risk for stroke defined by the following:
1. 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:
2. 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).
3. History of stroke or transient ischemic attack within the past 5 years
* Able to participate in group sessions
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT04685408). StuddyBuddy aggregates publicly available trial information.