Clinical trial NCT04402125: Reducing Stroke Risk in African-American Men
Official title: Reducing Stroke Risk in African-American Men
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-05-26
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: TEAM vs WL change in systolic BP
timeFrame: Baseline to 6-month follow up
Secondary outcomes:
measure: TEAM vs WL change in diastolic BP
timeFrame: Baseline to 6-month follow up
measure: TEAM vs WL change in cholesterol
timeFrame: Baseline to 6-month follow up
measure: TEAM vs WL change in HDL
timeFrame: Baseline to 6-month follow up
measure: TEAM vs WL change in LDL
timeFrame: Baseline to 6-month follow up
measure: TEAM vs WL change in triglycerides
timeFrame: Baseline to 6-month follow up
measure: TEAM vs WL change in BMI
timeFrame: Baseline to 6-month follow up
measure: TEAM vs WL change in HbA1c
timeFrame: Baseline to 6-month follow up
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Still CH, Burant C, Moore S, Einstadter D, Killion C, Modlin C, Sundararajan S, Thornton JD, Wright JT Jr, Sajatovic M. The Targeted Management (TEAM) Intervention for Reducing Stroke Risk in African American Men: Rationale and Study Design of a Prospective Randomized Controlled Trial. J Multidiscip Healthc. 2021 Feb 23;14:513-522. doi: 10.2147/JMDH.S288753. eCollection 2021.