Reducing Stroke Risk in African-American Men

Stroke Clinical Trial

— TEAM2  

Official title:

Reducing Stroke Risk in African-American Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402125
• Other study ID #: R01NR018023
• Secondary ID: R01NR018023
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Case Western Reserve University
• Contact: Research Manager
• Phone: 888-819-0004
• Email: carla.conroy[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

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.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEAM vs WL change in systolic BP	TEAM vs WL change in systolic BP	Baseline to 6-month follow up
Secondary	TEAM vs WL change in diastolic BP	TEAM vs WL change in diastolic BP	Baseline to 6-month follow up
Secondary	TEAM vs WL change in cholesterol	TEAM vs WL change in cholesterol	Baseline to 6-month follow up
Secondary	TEAM vs WL change in HDL	TEAM vs WL change in HDL	Baseline to 6-month follow up
Secondary	TEAM vs WL change in LDL	TEAM vs WL change in LDL	Baseline to 6-month follow up
Secondary	TEAM vs WL change in triglycerides	TEAM vs WL change in triglycerides	Baseline to 6-month follow up
Secondary	TEAM vs WL change in BMI	TEAM vs WL change in BMI	Baseline to 6-month follow up
Secondary	TEAM vs WL change in HbA1c	TEAM vs WL change in HbA1c	Baseline to 6-month follow up