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Reducing Stroke Risk in African-American Men

NCT ID: NCT04402125

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2025-09-08

Brief Summary

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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

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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.

Conditions

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Stroke Transient Ischemic Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

TargEted MAnageMent Intervention (TEAM)

Intervention Type 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:

1. 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.
2. 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.
3. 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.

Waitlist

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

Group Type OTHER

TargEted MAnageMent Intervention (TEAM)

Intervention Type 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:

1. 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.
2. 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.
3. 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.

Interventions

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TargEted MAnageMent Intervention (TEAM)

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:

1. 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.
2. 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.
3. 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


1. Age range from 18 to 90
2. Able to participate in group sessions


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


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

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



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


1\. Individuals who are unable or unwilling to provide written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Martha Sajatovic, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha Sajatovic, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33654407 (View on PubMed)

Other Identifiers

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R01NR018023

Identifier Type: NIH

Identifier Source: secondary_id

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R01NR018023

Identifier Type: NIH

Identifier Source: org_study_id

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