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

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment TargEted MAnageMent Intervention (TEAM) for reducing stroke risk in African-American men?

Research shows that a self-management approach like TEAM can help reduce stroke risk factors in African American men who have had a stroke or transient ischemic attack (a temporary period of symptoms similar to a stroke). Additionally, nurse case management, which includes self-management strategies, has been effective in improving blood pressure control and medication adherence, which are important for stroke prevention. ^{1 2 3 4 5}

Is the Targeted Management Intervention (TEAM) generally safe for humans?

The available research on the Targeted Management Intervention (TEAM) for stroke risk reduction in African American men does not specifically mention safety concerns, suggesting it is generally considered safe for human use. ^{3 4 6 7 8}

What makes the TEAM treatment unique for reducing stroke risk in African-American men?

The TEAM treatment is unique because it focuses on a self-management approach specifically designed for African-American men, aiming to reduce stroke risk by addressing psychosocial challenges and improving adherence to risk factor management. ^{4 5 9 10 11}

Research Team

Martha Sajatovic, MD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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 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]

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]

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]

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]

References

1. Finland pubmed.ncbi.nlm.nih.gov

Ischemic stroke and TIA. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Quality Enhancement Research Initiative in stroke: prevention, treatment, and rehabilitation. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Nurse case management to improve risk reduction outcomes in a stroke prevention clinic. [2022]

4. United States 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. [2023]

5. Iran pubmed.ncbi.nlm.nih.gov

Process and Results of Implementing Disease Management Program in Patients with First-time Ischemic Stroke. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. [2006]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Secondary Stroke Risk Reduction in Black Adults: a Systematic Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Stroke in Black Americans. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Informing Policy for Reducing Stroke Health Disparities from the Experience of African-American Male Stroke Survivors. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Awareness, treatment, and control of vascular risk factors in African Americans with stroke. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Cerebrovascular disease in blacks. [2022]