Clinical trial NCT04685408: A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk Ugandans
Official title: A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Fogarty International Center of the National Institute of Health
First posted: 2020-12-28
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline systolic blood pressure (BP) at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
city: Kampala
country: Uganda
facility: Nsambya Hospital
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
affiliation: Case Western Reserve University
name: Marta Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaddumukasa M, Najjuma J, Mbalinda SN, Kaddumukasa MN, Nakibuuka J, Burant C, Moore S, Blixen C, Katabira ET, Sajatovic M. Reducing stroke burden through a targeted self-management intervention for reducing stroke risk factors in high-risk Ugandans: A protocol for a randomized controlled trial. PLoS One. 2021 Jun 22;16(6):e0251662. doi: 10.1371/journal.pone.0251662. eCollection 2021.