Reducing Stroke Risk in African-American Men

Not Applicable

Recruiting

• Conditions: Stroke; Transient Ischemic Attack
• Interventions: Behavioral: TargEted MAnageMent Intervention (TEAM)

• Registration Number: NCT04402125
• Lead Sponsor: Case Western Reserve University

Brief Summary

The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years.

Detailed Description

The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years. TEAM features a nurse-led, person-centered, holistic intervention that takes advantage of existing strengths in AA families/communities. TEAM uses peer educator dyads (PEDs) to provide support and model behaviors. The PED consists of an AA man peer educator (PE) with experience in managing his own stroke risk and a care partner. A care partner is someone who is the family member, friend or other individual of someone who has had a stroke or TIA. A care partner can be associated with a PE but they do not have to be. PEs and care partners will be matched depending on schedules and availability and may not always be members of the same household. The nurse and PED co-deliver TEAM to an AA male patient who has experienced stroke or TIA. Patients are also encouraged to include a family, friend, or other individual important his stroke recovery in the TEAM programming. The intervention is a practical approach suitable for implementation in specialty, primary care or community settings, and has the potential to reverse the unacceptably high morbidity seen in AA men due to stroke-related disorders.

Study Timeline

• Study Start: 2020-05-05
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Waitlist	TargEted MAnageMent Intervention (TEAM)	Participants randomized to waitlist for 6 months, then offered the intervention for 6 months
Intervention	TargEted MAnageMent Intervention (TEAM)	Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up

Primary Outcome Measures

Name	Time	Method
TEAM vs WL change in systolic BP	Baseline to 6-month follow up	TEAM vs WL change in systolic BP

Secondary Outcome Measures

Name	Time	Method
TEAM vs WL change in cholesterol	Baseline to 6-month follow up	TEAM vs WL change in cholesterol
TEAM vs WL change in triglycerides	Baseline to 6-month follow up	TEAM vs WL change in triglycerides
TEAM vs WL change in diastolic BP	Baseline to 6-month follow up	TEAM vs WL change in diastolic BP
TEAM vs WL change in HbA1c	Baseline to 6-month follow up	TEAM vs WL change in HbA1c
TEAM vs WL change in LDL	Baseline to 6-month follow up	TEAM vs WL change in LDL
TEAM vs WL change in HDL	Baseline to 6-month follow up	TEAM vs WL change in HDL
TEAM vs WL change in BMI	Baseline to 6-month follow up	TEAM vs WL change in BMI

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States