Reducing Stroke Risk in African-American Men

NCT04402125 | Completed

• 1 other identifier: R01NR018023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• TEAM vs WL change in systolic BP

  TEAM vs WL change in systolic BP

  Baseline to 6-month follow up

Secondary Outcomes (7)

• TEAM vs WL change in diastolic BP

  Baseline to 6-month follow up

• TEAM vs WL change in cholesterol

  Baseline to 6-month follow up

• TEAM vs WL change in HDL

  Baseline to 6-month follow up

• TEAM vs WL change in LDL

  Baseline to 6-month follow up

• TEAM vs WL change in triglycerides

  Baseline to 6-month follow up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: TargEted MAnageMent Intervention (TEAM)

Waitlist

OTHER

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

Behavioral: TargEted MAnageMent Intervention (TEAM)

Interventions

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: 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; Waitlist

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 33654407 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 26, 2020
• Study Start: May 5, 2020
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)