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COMPLETED
NCT04685408
NA

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

Sponsor: Case Western Reserve University

View on ClinicalTrials.gov

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).

Official title: A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2022-05-13

Completion Date

2024-09-03

Last Updated

2026-08-07

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

TEAM

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.

BEHAVIORAL

ETAU

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.

Locations (3)

Mulago Hospital

Kampala, Uganda

Nsambya Hospital

Kampala, Uganda

Mbarara Regional Referral Hospital

Mbarara, Uganda