Reducing Stroke Risk in African-American Men (TEAM2)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Transient Ischemic Attack
• Intervention / Treatment: Behavioral: TargEted MAnageMent Intervention (TEAM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Manager; Phone Number: 888-819-0004; Email: carla.conroy@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Western Reserve University
      • Principal Investigator: Martha Sajatovic, MD
      • Contact: Phone Number: 888-819-0004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up	Behavioral: 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: 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.
Other: Waitlist; Participants randomized to waitlist for 6 months, then offered the intervention for 6 months	Behavioral: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAM vs WL change in systolic BP	TEAM vs WL change in systolic BP	Baseline to 6-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAM vs WL change in diastolic BP	TEAM vs WL change in diastolic BP	Baseline to 6-month follow up
TEAM vs WL change in cholesterol	TEAM vs WL change in cholesterol	Baseline to 6-month follow up
TEAM vs WL change in HDL	TEAM vs WL change in HDL	Baseline to 6-month follow up
TEAM vs WL change in LDL	TEAM vs WL change in LDL	Baseline to 6-month follow up
TEAM vs WL change in triglycerides	TEAM vs WL change in triglycerides	Baseline to 6-month follow up
TEAM vs WL change in BMI	TEAM vs WL change in BMI	Baseline to 6-month follow up
TEAM vs WL change in HbA1c	TEAM vs WL change in HbA1c	Baseline to 6-month follow up

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Martha Sajatovic, MD, Case Western Reserve University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: R01NR018023 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No