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Targeted Management Intervention for Stroke Risk Reduction in African-American Men (TEAM2 Trial)
N/A
Recruiting
Led By Martha Sajatovic, MD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6-month follow up
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of a targeted management intervention to a wait-list control in African American men who have experienced a stroke or TIA.
Who is the study for?
This trial is for African American men aged 18-90 who have had a stroke or TIA in the past 5 years, with a Barthel Index score over 60. Participants must be able to attend group sessions and provide consent. Excludes those with strokes due to sickle-cell disease or unwilling to consent.
What is being tested?
The study compares the effects of a TargEted MAnageMent Intervention (TEAM) against a wait-list control over six months on African American men who've experienced stroke/TIA, assessing how well TEAM helps reduce future stroke risk.
What are the potential side effects?
Since this trial involves management interventions rather than medications, typical drug side effects are not expected. However, there may be indirect effects related to lifestyle changes or stress from participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6-month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6-month follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
TEAM vs WL change in systolic BP
Secondary study objectives
TEAM vs WL change in BMI
TEAM vs WL change in HDL
TEAM vs WL change in HbA1c
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: WaitlistExperimental Treatment1 Intervention
Participants randomized to waitlist for 6 months, then offered the intervention for 6 months
Group II: InterventionExperimental Treatment1 Intervention
Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up
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Who is running the clinical trial?
Case Western Reserve UniversityLead Sponsor
307 Previous Clinical Trials
250,473 Total Patients Enrolled
19 Trials studying Stroke
9,693 Patients Enrolled for Stroke
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,613 Total Patients Enrolled
15 Trials studying Stroke
7,163 Patients Enrolled for Stroke
Martha Sajatovic, MDPrincipal Investigator - Case Western Reserve University
Case Western Reserve University
20 Previous Clinical Trials
1,406 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who have had a stroke because of sickle-cell disease.You have a Barthel Index (BI) score of more than 60.You have had a stroke or a transient ischemic attack (TIA).You have had a stroke caused by sickle-cell disease.You must be between 18 and 90 years old to participate in the study.You had a stroke or TIA (mini-stroke) within the past 5 years.Peer educators between 18 and 90 years old can apply.The peer educator care partner should be between 18 and 90 years old.The person helping with the study is a family member, friend, or someone else who is important in the recovery of the person who had a stroke.You are an African American man who has identified as a peer educator.The care partner should be between 18 and 90 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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