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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR018023 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up |
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| Waitlist | Other | Participants randomized to waitlist for 6 months, then offered the intervention for 6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TargEted MAnageMent Intervention (TEAM) | Behavioral | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| TEAM vs WL change in systolic BP | TEAM vs WL change in systolic BP | Baseline to 6-month follow up |
| 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 |
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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
1. Individuals who are unable or unwilling to provide written informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33654407 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2026 | Apr 28, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |