Targeted Management Intervention for Stroke Risk Reduction in African-American Men

(TEAM2 Trial)

Overseen By Research Manager

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Sickle-cell disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Targeted Management Intervention (TEAM) to reduce stroke risk in African American men. It will compare the effects of this intervention with a wait-list group over six months. The trial seeks African American men who have experienced a stroke or a TIA (mini-stroke) in the past five years and can participate in group sessions. Participants will either begin the intervention or join a waitlist before eventually receiving the intervention. The trial aims to discover better ways to manage stroke risk and improve recovery outcomes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could significantly enhance stroke management and recovery for African American men.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TargEted MAnageMent Intervention is safe for African American men who have experienced a stroke or TIA?

Research shows that the TargEted MAnageMent Intervention (TEAM) aims to lower stroke risk in African-American men. Earlier studies have shown promising results and reported no major safety issues, indicating that the intervention is generally safe.

For those considering joining a clinical trial, this is encouraging. Although this trial falls under the "Not Applicable" category, the absence of serious side effects in past research provides reassurance about the safety of TEAM. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TargEted MAnageMent Intervention (TEAM) for reducing stroke risk in African-American men because it offers a personalized approach. Unlike the usual care options like medication and lifestyle changes that are often broadly applied, TEAM tailors strategies specifically to individual needs and circumstances. This intervention aims to empower participants through a combination of education, support, and personalized health management, potentially leading to more effective and sustainable risk reduction.

What evidence suggests that the TargEted MAnageMent Intervention could be effective for stroke risk reduction in African-American men?

Research has shown that the TargEted MAnageMent Intervention (TEAM), which participants in this trial may receive, can help reduce stroke risk factors in African American men. In earlier studies, participants in the TEAM program understood stroke risk factors better than those who did not participate. This indicates that TEAM helps individuals learn about and manage their health more effectively. The program emphasizes lifestyle changes to lower stroke risk and reduce health disparities. Early results are promising, suggesting that TEAM could be a useful tool in preventing future strokes. ^{1 2 4 6 7}

Who Is on the Research Team?

Martha Sajatovic, MD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

RCT participant: Self-identified African American male

RCT participant: Able to participate in group sessions

Care Partner: Able to participate in group sessions

Exclusion Criteria

RCT participant: Individuals who are unable or unwilling to provide written informed consent

Care Partner participant: Individuals who are unable or unwilling to provide written informed consent

Peer Educator: Individuals who are unable or unwilling to provide written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TargEted MAnageMent Intervention (TEAM) for 6 months

6 months

Regular visits with nurse and peer educator dyads

Follow-up

Participants are monitored for changes in systolic BP, cholesterol, triglycerides, diastolic BP, BMI, LDL, HbA1c, and HDL

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TargEted MAnageMent Intervention (TEAM)

Trial Overview 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.

How Is the Trial Designed?

Group I: Waitlist Experimental Treatment 1 Intervention

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

Group II: Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The TargetEd MAnageMent Intervention (TEAM) significantly reduced systolic blood pressure in African American men at risk for stroke compared to treatment as usual, with improvements noted in glycosylated hemoglobin (HbA1c) and HDL cholesterol after 6 months.

Qualitative feedback from TEAM participants indicated enhanced awareness of stroke risk factors and the benefits of group support, suggesting that self-management training can positively influence health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Targeted Self-Management Approach for Reducing Stroke Risk Factors in African American Men Who Have Had a Stroke or Transient Ischemic Attack. Sajatovic, M., Tatsuoka, C., Welter, E., et al.[2023]

A systematic review of studies focused on Black adults showed that behavioral interventions effectively reduce secondary stroke risk, particularly through education on risk factors and healthy coping strategies.

Improvements in biological outcomes, such as cholesterol control and systolic blood pressure, were observed, especially in individuals with poorly controlled blood pressure at the start of the interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary Stroke Risk Reduction in Black Adults: a Systematic Review. Cao, C., Jain, N., Lu, E., et al.[2023]

Black Americans experience a higher incidence of strokes compared to other racial and ethnic groups in the U.S., which may be influenced by factors such as poor awareness of stroke symptoms, higher rates of vascular risk factors, and limited access to healthcare.

There is a significant under-representation of Black Americans in stroke-related observational studies and clinical trials, leading to gaps in knowledge about effective prevention and treatment strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke in Black Americans. Ruland, S., Gorelick, PB.[2022]

In a study of 1,086 African American patients with a history of stroke, significant gaps were found in the awareness and control of key cardiovascular risk factors, including diabetes, hypertension, and hypercholesterolemia.

Only 30% of treated hypertensive patients achieved target blood pressure levels, and 38% of those with hypercholesterolemia still had high cholesterol, highlighting the need for improved management strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness, treatment, and control of vascular risk factors in African Americans with stroke. Ruland, S., Raman, R., Chaturvedi, S., et al.[2022]

African-American men face significant psychosocial barriers to managing stroke risk factors, including low trust in healthcare providers, limited social support, and mental health challenges like depression.

To effectively reduce stroke disparities, policies and programs must address these specific challenges and improve infrastructure for sharing successful practices tailored to the needs of African-American communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing Policy for Reducing Stroke Health Disparities from the Experience of African-American Male Stroke Survivors. Perzynski, A., Blixen, C., Cage, J., et al.[2022]

Stroke is a significant health issue among black Americans, yet it has not been studied as thoroughly as it should be, highlighting a gap in research and understanding.

The paper discusses strategies for evaluating and managing cerebrovascular disease in this population, emphasizing the need for tailored approaches to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebrovascular disease in blacks. Caplan, LR., Cooper, ES.[2022]

A disease management program for cardiovascular disease (CVD) risk reduction, involving 148 patients with limited healthcare access, led to significant decreases in systolic blood pressure and low-density lipoprotein cholesterol compared to usual care.

The program, which included lifestyle changes and medication, successfully helped more patients move from high-risk to lower-risk categories for CVD, demonstrating its effectiveness in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. Haskell, WL., Berra, K., Arias, E., et al.[2006]

A pilot study involving 20 clients tested an expanded nurse case management model to improve blood pressure control and adherence to medication in stroke prevention, showing it is feasible with minimal resource impact.

After six months, clients in the program experienced significant reductions in blood pressure and improved self-efficacy and adherence to their medication regimens, indicating the model's potential effectiveness in preventing recurrent strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse case management to improve risk reduction outcomes in a stroke prevention clinic. Ireland, S., MacKenzie, G., Gould, L., et al.[2022]

The lack of a systematic approach to stroke prevention and treatment within the Veterans Health Administration (VHA) has contributed to lower compliance with recommended practices and higher stroke rates, highlighting the need for improved care strategies.

Proposed objectives include enhancing access to long-term anticoagulation services, developing risk-adjusted models for carotid endarterectomy, and establishing a systematic acute stroke management system to improve overall stroke care for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Enhancement Research Initiative in stroke: prevention, treatment, and rehabilitation. Oddone, E., Brass, LM., Booss, J., et al.[2019]

Early diagnosis of transient ischemic attack (TIA) and stroke symptoms is crucial for improving patient outcomes, emphasizing the need for rapid access to thrombolytic and thrombectomy therapies.

Long-term recovery is enhanced by thorough screening for underlying causes like atrial fibrillation and carotid stenosis, along with comprehensive care in specialized stroke units with multi-professional rehabilitation teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischemic stroke and TIA. [2018]

The disease management program (DMP) significantly improved treatment outcomes for first-time ischemic stroke patients, with effective rates of 69.9% and 76.6% in two hospitals, compared to 60.8% and 62.7% in non-DMP groups.

Patients in the DMP group had a shorter average length of stay and lower hospitalization costs, indicating that DMP not only enhances efficacy but also offers a more cost-effective approach to stroke management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process and Results of Implementing Disease Management Program in Patients with First-time Ischemic Stroke. Yang, HR., Ma, L., Jiang, YF., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7914069/

The Targeted Management (TEAM) Intervention for ... Targeted Management (TEAM) is a novel intervention, developed by this study team, to promote secondary stroke-risk reduction in AA men at high- ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0330606

A 6-month, prospective randomized controlled trial of the ... This 6-month, prospective randomized controlled trial (RCT) compared a novel stroke risk reduction approach (TargetEd manAgeMent Intervention (TEAM)) vs.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/08/NCT04685408/Prot_SAP_000.pdf

A TargEted MAnageMent Intervention for Reducing Stroke Risk ... The proposed project is a prospective, randomized effectiveness-implementation trial of TargEted MAnageMent. Intervention (TEAM. N= 123) vs enhanced treatment ...

4. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.116.016229

Effectiveness of an Intervention to Improve Risk Factor ... Conclusions— Overall knowledge of risk factors of stroke or transient ischemic attack was better in the intervention group than controls. ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33654407/

The Targeted Management (TEAM) Intervention for ... In addition, the TEAM approach may help reduce stroke risk factors and health disparities in AA men. Clinicaltrialsgov identifier: NCT04402125.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT04402125

Reducing Stroke Risk in African-American Men (TEAM2) 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) ...

7. researchgate.net researchgate.net/publication/349512603_The_Targeted_Management_TEAM_Intervention_for_Reducing_Stroke_Risk_in_African_American_Men_Rationale_and_Study_Design_of_a_Prospective_Randomized_Controlled_Trial

(PDF) The Targeted Management (TEAM) Intervention for ... We hypothesize that AA men in TEAM will have significantly lower systolic BP and higher HDL when compared to AA men in the Wait-list control group at 6-month.