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Completed

NCT Number: NCT04402125

Reducing Stroke Risk in African-American Men

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for RCT participant:

  • Age range 18 to 90
  • Self-identified African American male
  • 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
  • Barthel Index (BI) score of >= 40
  • Able to participate in group sessions

Inclusion criteria

for Care Partner

  • Age range from 18 to 90
  • Able to participate in group sessions

Inclusion criteria

for peer educator:

  • Age range: from 18 to 90
  • Self-identified African American male
  • Have had a stroke or TIA
  • Able to participate in group sessions

Inclusion criteria

for Peer Educator Care Partner

  • Age range: from 18 to 90
  • Able to participate in group sessions
  • 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

  • Individuals who are unable or unwilling to provide written informed consent
  • 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

  • Individuals who are unable or unwilling to provide written informed consent
  • Individuals who have had stroke due to sickle-cell disease

Exclusion criteria

for Peer Educator's Care Partner

  • Individuals who are unable or unwilling to provide written informed consent

Treatment and study plan

TargEted MAnageMent Intervention (TEAM)

Behavioral

TEAM targets acquisition of self-management expertise and use of healthy behaviors that are intended to reduce stroke risk and burden. TEAM participants will continue in their regular medical care, supplemented by the TEAM intervention. Components are as follows:

  • A 60 minute initial session in which the nurse and the PED meet with the patient who has experienced stroke or TIA. The initial session will cover introductions, orientation, and logistic planning.
  • Five 60-minute group sessions with 6-10 stroke survivors (and their care partners as applicable) held approximately 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 week after enrollment. Sessions are co-lead by a nurse and a PED.
  • Six brief telephone sessions implemented after the conclusion of the 5 TEAM group sessions. Calls will be conducted every 2 weeks for 12 weeks. Calls will reinforce group session content, provide social support and facilitate linkage with other care providers.

Primary outcomes

  1. TEAM vs WL change in systolic BP

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in systolic BP

Secondary outcomes

  1. TEAM vs WL change in diastolic BP

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in diastolic BP

  2. TEAM vs WL change in cholesterol

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in cholesterol

  3. TEAM vs WL change in HDL

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in HDL

  4. TEAM vs WL change in LDL

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in LDL

  5. TEAM vs WL change in triglycerides

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in triglycerides

  6. TEAM vs WL change in BMI

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in BMI

  7. TEAM vs WL change in HbA1c

    Time frame: Baseline to 6-month follow up

    TEAM vs WL change in HbA1c

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: TEAM2

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 26, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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