CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 276 enrolled
Drug / intervention
TEAM +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04685408
NCT04685408N/ACompleted

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

Case Western Reserve University·interventional·Posted Dec 28, 2020·Updated Aug 3, 2025

In Brief

A clinical study evaluating TEAM and ETAU for Stroke. Completed, enrolled 276 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUganda

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 28, 2020
Enrollment StartMay 13, 2022
Primary CompletionMar 6, 2024
Study CompletionSep 3, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.5 years ago

Interventions

TEAMbehavioral

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.

ETAUbehavioral

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.