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Reducing Stroke Risk in African-American Men (TEAM2)

Primary Purpose

Stroke, Transient Ischemic Attack

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TargEted MAnageMent Intervention (TEAM)
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 5 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 >60
  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

Sites / Locations

  • Case Western Reserve UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Waitlist

Arm Description

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

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

Outcomes

Primary Outcome Measures

TEAM vs WL change in systolic BP
TEAM vs WL change in systolic BP

Secondary Outcome Measures

TEAM vs WL change in diastolic BP
TEAM vs WL change in diastolic BP
TEAM vs WL change in cholesterol
TEAM vs WL change in cholesterol
TEAM vs WL change in HDL
TEAM vs WL change in HDL
TEAM vs WL change in LDL
TEAM vs WL change in LDL
TEAM vs WL change in triglycerides
TEAM vs WL change in triglycerides
TEAM vs WL change in BMI
TEAM vs WL change in BMI
TEAM vs WL change in HbA1c
TEAM vs WL change in HbA1c

Full Information

First Posted
May 15, 2020
Last Updated
December 13, 2022
Sponsor
Case Western Reserve University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04402125
Brief Title
Reducing Stroke Risk in African-American Men
Acronym
TEAM2
Official Title
Reducing Stroke Risk in African-American Men
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up
Arm Title
Waitlist
Arm Type
Other
Arm Description
Participants randomized to waitlist for 6 months, then offered the intervention for 6 months
Intervention Type
Behavioral
Intervention Name(s)
TargEted MAnageMent Intervention (TEAM)
Intervention Description
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 Outcome Measure Information:
Title
TEAM vs WL change in systolic BP
Description
TEAM vs WL change in systolic BP
Time Frame
Baseline to 6-month follow up
Secondary Outcome Measure Information:
Title
TEAM vs WL change in diastolic BP
Description
TEAM vs WL change in diastolic BP
Time Frame
Baseline to 6-month follow up
Title
TEAM vs WL change in cholesterol
Description
TEAM vs WL change in cholesterol
Time Frame
Baseline to 6-month follow up
Title
TEAM vs WL change in HDL
Description
TEAM vs WL change in HDL
Time Frame
Baseline to 6-month follow up
Title
TEAM vs WL change in LDL
Description
TEAM vs WL change in LDL
Time Frame
Baseline to 6-month follow up
Title
TEAM vs WL change in triglycerides
Description
TEAM vs WL change in triglycerides
Time Frame
Baseline to 6-month follow up
Title
TEAM vs WL change in BMI
Description
TEAM vs WL change in BMI
Time Frame
Baseline to 6-month follow up
Title
TEAM vs WL change in HbA1c
Description
TEAM vs WL change in HbA1c
Time Frame
Baseline to 6-month follow up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for RCT participant: Age range 18 to 90 Self-identified African American male Have had a stroke or TIA in the past 5 years based on date of hospital discharge from an acute stroke program or Emergency Room/physician visit for TIA Barthel Index (BI) score of >60 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 1. Individuals who are unable or unwilling to provide written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Manager
Phone
888-819-0004
Email
carla.conroy@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
888-819-0004
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33654407
Citation
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.
Results Reference
derived

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Reducing Stroke Risk in African-American Men

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