Case Western Reserve University
Cleveland, Ohio, 44106, United States
NCT Number: NCT04402125
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.
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Notify Me18 year–90 year
Male
Interventional
Not applicable
Cleveland, Ohio, 44106, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for RCT participant:
Inclusion criteria
for Care Partner
Inclusion criteria
for peer educator:
Inclusion criteria
for Peer Educator Care Partner
Exclusion criteria
for RCT participant
Exclusion criteria
for Care Partner participant 1. Individuals who are unable or unwilling to provide written informed consent
Exclusion criteria
for Peer Educator
Exclusion criteria
for Peer Educator's Care Partner
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:
Time frame: Baseline to 6-month follow up
TEAM vs WL change in systolic BP
Time frame: Baseline to 6-month follow up
TEAM vs WL change in diastolic BP
Time frame: Baseline to 6-month follow up
TEAM vs WL change in cholesterol
Time frame: Baseline to 6-month follow up
TEAM vs WL change in HDL
Time frame: Baseline to 6-month follow up
TEAM vs WL change in LDL
Time frame: Baseline to 6-month follow up
TEAM vs WL change in triglycerides
Time frame: Baseline to 6-month follow up
TEAM vs WL change in BMI
Time frame: Baseline to 6-month follow up
TEAM vs WL change in HbA1c
Case Western Reserve University
Other
Acronym: TEAM2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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