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

NCT04685408 | Completed Results DMC

• 2 other identifiers: STUDY202008821R01NS118544
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 3

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).

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Systolic Blood Pressure (BP) at 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

  Baseline and 6 months

Study Arms (2)

TargEted MAnageMent Intervention (TEAM)

EXPERIMENTAL

This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM)

Behavioral: TEAM

Enhanced treatment as usual (ETAU)

ACTIVE COMPARATOR

This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).

Behavioral: ETAU

Interventions

TEAM BEHAVIORAL

TEAM is informed by principles of social cognitive theory TEAM uses nurses and peer educator dyads (PEDs) composed of patients and their care partners to co-deliver an intervention intended to help reduce future stroke risk. Team begins with one 60-minute 1:1 orientation session, in which the nurse and PED meet with the patient and his/her care partner. This is followed by 6 hour-long group sessions with 6-8 patients and their care partners held approximately weekly. The first orientation session will be done approximately 1 week post baseline, followed by group sessions were done at 2, 4, 6, 8, 10 and 12 weeks post-baseline.

TargEted MAnageMent Intervention (TEAM)

ETAU BEHAVIORAL

ETAU will consist of an orientation visit with a nurse who will provide patient-education materials on stroke risk adapted from the American Heart Association materials and cover common risk factors such as hypertension, obesity, high salt/high fat diet and diabetes. Patients will also receive basic written information in their language of preference and tailored to the reading level of most patients at the clinic. Patients will be offered the opportunity to bring a family member with them to this visit who may also ask questions and who can assist them with understanding written materials for those with limited literacy. The nurse in ETAU will then follow-up with participants with a series of 9 brief phone calls spaced out over the course of 6 months (approximately every 2 weeks during months 1 and 2, then approximately monthly thereafter). Content will reinforce materials provided in the orientation visit and the nurse will be available to answer questions that may arise.

Enhanced treatment as usual (ETAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

Mulago Hospital

Kampala, Uganda

Location

Nsambya Hospital

Kampala, Uganda

Location

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

Related Publications (2)

• Kaddumukasa M, Kaddumukasa M, Mbalinda SN, Najjuma J, Nakibuuka J, Birungi D, Conroy C, Yala J, Mugenyi L, Burant CJ, Moore S, Katabira ET, Sajatovic M. A 6-month, prospective randomized controlled trial of the TargetEd MAnageMent (TEAM) intervention vs. enhanced treatment as usual among Ugandans at risk for stroke. PLoS One. 2025 Aug 22;20(8):e0330606. doi: 10.1371/journal.pone.0330606. eCollection 2025.

  PMID: 40844998 DERIVED

• 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.

  PMID: 34157024 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Martha Sajatovic
• Organization: Case Western Reserve University

martha.sajatovic@uhhospitals.org

216-844-2808

Study Officials

• Marta Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: May 13, 2022
• Primary Completion: March 6, 2024
• Study Completion: September 3, 2024
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

UG (3)