Reducing Stroke Risk in African-American Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- TEAM vs WL change in systolic BP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •for RCT participant:
- •Age range 18 to 90
- •Self-identified African American male
- •Have had a stroke or TIA in the past 10 years based on date of hospital discharge from an acute stroke program or Emergency Room/physician visit for TIA
- •Barthel Index (BI) score of >= 40
- •Able to participate in group sessions
- •Inclusion Criteria for Care Partner
- •Age range from 18 to 90
- •Able to participate in group sessions
- •Inclusion criteria for peer educator:
- •Age range: from 18 to 90
- •Self-identified African American male
- •Have had a stroke or TIA
- •Able to participate in group sessions
- •Inclusion Criteria for Peer Educator Care Partner
- •Age range: from 18 to 90
- •Able to participate in group sessions
- •Is either a family member, friend or other individual who is important in an enrolled peer educator's stroke recovery OR the family member, friend or other individual of someone who has had a stroke or TIA and is/was important in their stroke recovery
排除标准
- •for RCT participant
- •Individuals who are unable or unwilling to provide written informed consent
- •Individuals who have had stroke due to sickle-cell disease
- •Exclusion Criteria for Care Partner participant
- •Individuals who are unable or unwilling to provide written informed consent
- •Exclusion Criteria for Peer Educator
- •Individuals who are unable or unwilling to provide written informed consent
- •Individuals who have had stroke due to sickle-cell disease
- •Exclusion Criteria for Peer Educator's Care Partner
- •1. Individuals who are unable or unwilling to provide written informed consent
研究组 & 干预措施
Intervention
Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up
干预措施: TargEted MAnageMent Intervention (TEAM) (Behavioral)
Waitlist
Participants randomized to waitlist for 6 months, then offered the intervention for 6 months
干预措施: TargEted MAnageMent Intervention (TEAM) (Behavioral)
结局指标
主要结局
TEAM vs WL change in systolic BP
时间窗: Baseline to 6-month follow up
TEAM vs WL change in systolic BP
次要结局
- TEAM vs WL change in cholesterol(Baseline to 6-month follow up)
- TEAM vs WL change in triglycerides(Baseline to 6-month follow up)
- TEAM vs WL change in diastolic BP(Baseline to 6-month follow up)
- TEAM vs WL change in HbA1c(Baseline to 6-month follow up)
- TEAM vs WL change in LDL(Baseline to 6-month follow up)
- TEAM vs WL change in HDL(Baseline to 6-month follow up)
- TEAM vs WL change in BMI(Baseline to 6-month follow up)
研究者
Martha Sajatovic, MD
Professor
Case Western Reserve University
