Reducing stroke risk in African-American men
This study is testing a new support program for African American men who have had a stroke or TIA in the last five years to see if it can help reduce their risk of having another stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04402125 on ClinicalTrials.gov |
What this trial studies
This project is a 6-month prospective randomized controlled trial that evaluates the effects of a targeted management intervention (TEAM) compared to a wait-list control in African American men who have experienced a stroke or transient ischemic attack (TIA) within the past five years. The TEAM intervention is nurse-led and focuses on a holistic, person-centered approach that leverages the strengths of African American families and communities. It involves peer educator dyads who provide support and model healthy behaviors, encouraging participation from care partners. The intervention aims to be practical for implementation in various healthcare settings and seeks to address the high morbidity rates associated with stroke in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are African American men aged 18 to 90 who have had a stroke or TIA in the past 10 years and are able to participate in group sessions.
Not a fit: Patients who do not identify as African American or who have not experienced a stroke or TIA within the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce stroke risk and improve health outcomes for African American men.
How similar studies have performed: Other studies have shown success with similar community-based interventions aimed at reducing stroke risk, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for RCT participant: 1. Age range 18 to 90 2. Self-identified African American male 3. Have had a stroke or TIA in the past 10 years based on date of hospital discharge from an acute stroke program or Emergency Room/physician visit for TIA 4. Barthel Index (BI) score of \>= 40 5. Able to participate in group sessions Inclusion Criteria for Care Partner 1. Age range from 18 to 90 2. Able to participate in group sessions Inclusion criteria for peer educator: 1. Age range: from 18 to 90 2. Self-identified African American male 3. Have had a stroke or TIA 4. Able to participate in group sessions Inclusion Criteria for Peer Educator Care Partner 1. Age range: from 18 to 90 2. Able to participate in group sessions 3. Is either a family member, friend or other individual who is important in an enrolled peer educator's stroke recovery OR the family member, friend or other individual of someone who has had a stroke or TIA and is/was important in their stroke recovery Exclusion Criteria for RCT participant 1. Individuals who are unable or unwilling to provide written informed consent 2. Individuals who have had stroke due to sickle-cell disease Exclusion Criteria for Care Partner participant 1. Individuals who are unable or unwilling to provide written informed consent Exclusion Criteria for Peer Educator 1. Individuals who are unable or unwilling to provide written informed consent 2. Individuals who have had stroke due to sickle-cell disease Exclusion Criteria for Peer Educator's Care Partner 1. Individuals who are unable or unwilling to provide written informed consent
Where this trial is running
Cleveland, Ohio
- Case Western Reserve University — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Martha Sajatovic, MD — Case Western Reserve University
- Study coordinator: Research Manager
- Email: carla.conroy@uhhospitals.org
- Phone: 888-819-0004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.