A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk Ugandans

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: TEAM; Behavioral: ETAU

• Registration Number: NCT04685408
• Lead Sponsor: Case Western Reserve University

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 in reducing stroke risk in a 3-site, prospective, 6-month randomized controlled trial (RCT).

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 individuals with multiple stroke risk factors as defined above, 3 family members, 3 clinicians and 3 administrators who practice in the proposed study enrollment sites. The purpose of the SAB is to refine the TEAM intervention content to meet the needs of patients and professional healthcare stakeholders and suggest how TEAM might best be incorporated into clinical workflow, as well as give guidance and feedback on recruitment methods and advertisements.

Phase 2 of the project will be conducted across 3 Ugandan sites that will enroll a representative sample of Ugandans at risk for stroke (Kiruddu, Nsambya and Mbarara Hospitals and their associated outpatient clinics). In the RCT portion of the study, 246 participants will be randomized at baseline on a 1:1 basis to receive either TEAM (N= 123) or enhanced treatment as usual (ETAU) (N=123) and will be followed for a total of 6 months. Since stroke is a moderately long-term health outcome (years to decades) that typically occurs in the presence of one or more stroke risk factors, the project will focus on testing whether TEAM can modify well-established short-term biomarkers that predict stroke risk, specifically BP control, serum cholesterol and blood glucose control. Secondary outcomes of interest include additional stroke risk biomarkers, (HDL, LDL, triglycerides) diet, exercise, use of alcohol and tobacco, stroke knowledge/attitudes, stress, and treatment adherence with risk-reducing medications. We will also explore associations of age, gender, urban vs. rural residential status and stroke history (prior vs. no previous stroke) on TEAM outcomes. To help inform future scale-up should RCT findings be positive, we will assess barriers and facilitators to TEAM implementation using both qualitative and quantitative methods.

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2022-05-13
• Primary Completion: 2024-03-06
• Study Completion: 2024-09-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TargEted MAnageMent Intervention (TEAM)	TEAM	This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM)
Enhanced treatment as usual (ETAU)	ETAU	This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).

Primary Outcome Measures

Name	Time	Method
Change from baseline systolic blood pressure (BP) at 6 months	Baseline and 6 months	Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure

Trial Locations

Locations (3)

Mulago Hospital; 🇺🇬 Kampala, Uganda

Nsambya Hospital; 🇺🇬 Kampala, Uganda

Mbarara Regional Referral Hospital; 🇺🇬 Mbarara, Uganda