Reducing Stroke Risk in African-American Men (TEAM2)

Case Western Reserve University

Status: Active, not recruiting

Conditions: Stroke; Transient Ischemic Attack

Treatments: Behavioral: TargEted MAnageMent Intervention (TEAM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04402125

R01NR018023 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up

Treatment:

Behavioral: TargEted MAnageMent Intervention (TEAM)

Waitlist

Other group

Description:

Participants randomized to waitlist for 6 months, then offered the intervention for 6 months

Treatment:

Behavioral: TargEted MAnageMent Intervention (TEAM)