Targeted Management Intervention for Stroke Risk Reduction in African-American Men
(TEAM2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Western Reserve University
Disqualifiers: Sickle-cell disease, others
No Placebo Group
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.
12345Is 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.
34678What 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.
4591011Eligibility 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
+11 more
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
+3 more
Trial 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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Case Western Reserve UniversityCleveland, OH
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Who Is Running the Clinical Trial?
Case Western Reserve UniversityLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Ischemic stroke and TIA. [2018]The key steps to improve the outcome are early diagnosis of TIA and stroke symptoms, access to thrombolytic and thrombectomy therapy, urgent medical secondary prevention and acute care in a dedicated stroke unit where assessment and rehabilitation are started and carried out by a multi-professional rehabilitation team. Long-term outcome is also improved by reinforced screening of specific etiologies such as atrial fibrillation and carotid stenosis.
Quality Enhancement Research Initiative in stroke: prevention, treatment, and rehabilitation. [2019]Stroke is the third leading cause of death and a leading cause of adult disability in the United States. Both within and outside of the Veterans Health Administration (VHA), the lack of a systematic approach to stroke prevention and treatment may have contributed to reduced rates of compliance with recommended practices and increased rates of stroke. Gaps in the knowledge base inhibit a systematic approach to high-quality care within the veteran population. Initial recommendations for closing those gaps are proposed. In some cases (eg, systematic anticoagulation management), the VHA is perceived as a leader in applied research; therefore, a systematic national policy for implementing these clinics may significantly reduce stroke rates. In other areas (eg, carotid endarterectomy), databases exist that would help advance quality and outcomes, but short-term studies are necessary to establish their utility. To promote strategic improvement in prevention, treatment, and rehabilitation for veterans who may be at risk or have had a stroke, specific objectives are proposed to (1) identify best practices for the effective delivery of long-term anticoagulation and enhance veterans' access to these services, (2) develop risk-adjusted models for the surgical preventive procedure carotid endarterectomy to understand facility variation in outcomes so practices can be improved, (3) define a systematic acute stroke management system so that high-quality stroke-related care can be generalizable to a variety of VHA settings, and (4) assess the impact of poststroke rehabilitation on risk adjustment and the location of outcomes so as to facilitate the implementation of best rehabilitation practices.
Nurse case management to improve risk reduction outcomes in a stroke prevention clinic. [2022]Stroke prevention clinic health care professionals are mandated to provide early access to neurological consultation and treatment, diagnostic testing, and behavioural risk factor management for clients with transient ischemic attack or mild non-disabling stroke. Clinic nurses collaborate with clients and interprofessional teams to support risk factor reduction to prevent recurrent stroke events. Although hypertension is the most important modifiable risk factor for stroke, broader evidence indicates that adherence to prescribed medications may be less than 50%. One clinic identified a need to improve risk factor outcomes through identifying clients with uncontrolled hypertension, cognitive, self-eficacy and/or adherence characteristics predictive of non-achievement of blood pressure targets. To address this need, an expanded nurse case management care delivery model was pilot tested for feasibility in a participant sample of 20 clients. Motivational interviewing and self-management approaches were combined with interventions designed to improve adherence:facilitation of the simplification of medication routines, providing memory cues and home self-monitoring equipment, counselling, and six-month nursing follow-up. Results demonstrated that an expanded nurse case management model of care delivery is feasible with only a modest impact on clinic resources. At six months, there were significant reductions in blood pressure and increases in medication self-efficacy and adherence for selected clients identified with high risk for stroke and non-achievement of treatment outcomes.
A Targeted Self-Management Approach for Reducing Stroke Risk Factors in African American Men Who Have Had a Stroke or Transient Ischemic Attack. [2023]This study compared a novel self-management (TargetEd MAnageMent Intervention [TEAM]) versus treatment as usual (TAU) to reduce stroke risk in African American (AA) men.
Process and Results of Implementing Disease Management Program in Patients with First-time Ischemic Stroke. [2022]This study aimed to examine the effect of disease management program (DMP) on the patients with first-time ischemic stroke (IS).
Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. [2006]Few data exist on the effectiveness of cardiovascular disease (CVD) risk-reduction programs in patients with limited access to health care. The objective of this project was to evaluate a disease management approach to multifactor CVD risk reduction in patients with limited or no health insurance and low family income. Patients (n = 148) were recruited from not-for-profit or free clinics and hospitals and randomized to usual care or usual care plus team case management. Mean age was 59.3 years, 57% were women, 50% had less than a high school education, 57% were Hispanic, and 64% had no health insurance. All had > or =1 increased risk factor for CVD, and 24.5% had documented coronary artery disease. Follow-up measurements were obtained at 6 and 12 months. Primary outcomes were low-density lipoprotein cholesterol and systolic blood pressure. The disease management program was supervised by a physician, delivered by nurses and dietitians, and included comprehensive lifestyle changes and medications. Data were collected on 91% of patients at 12 months. Disease management produced clinically important decreases in selected risk factors compared with usual care, including systolic blood pressure (p
Secondary Stroke Risk Reduction in Black Adults: a Systematic Review. [2023]To address the fact that Black adults (BAs) experience significantly greater stroke burden than the general population, we conducted a systematic literature review which described evidence-based interventions targeting secondary stroke risk reduction in BAs.
Stroke in Black Americans. [2022]Black Americans bear a disproportionate stroke burden in the United States compared with other racial and ethnic groups. Poor stroke awareness, higher vascular risk factor burden, limited access to care, mistrust of the medical system, and inequities in diagnostic testing and treatment usage may account for some of the disparity. In addition, blacks have historically been under-represented in observational studies and clinical trials of stroke prevention and treatment. Therefore, our knowledge regarding stroke in black Americans is somewhat limited. This article provides an update on developments in our understanding regarding stroke in this at-risk population.
Informing Policy for Reducing Stroke Health Disparities from the Experience of African-American Male Stroke Survivors. [2022]The burden of stroke is severe among African-Americans. Despite overall declines in the rate of stroke since 2000, outcomes are largely unimproved or have worsened for African-American men. Adverse psychosocial challenges may hinder adherence to a regimen of risk factor reduction.
Awareness, treatment, and control of vascular risk factors in African Americans with stroke. [2022]To investigate control of risk factors in African American patients with previous stroke.
Cerebrovascular disease in blacks. [2022]Stroke in black Americans is an important health problem that has been understudied. A brief review of the pertinent literature and strategies for evaluating and managing patients with cerebrovascular disease are presented.