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

Sponsor
Case Western Reserve University
Study ID
NCT04685408
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
May 13, 2022
Status verified
Jul 2025
Primary completion
Mar 6, 2024
Completion
Sep 3, 2024

Study Design

Enrollment
276 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TargEted MAnageMent Intervention (TEAM)
    This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM)
  • Active Comparator: Enhanced treatment as usual (ETAU)
    This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).

Primary Outcome Measure

Change From Baseline Systolic Blood Pressure (BP) at 6 Months [ Time Frame: Baseline and 6 months ]

Related Studies