跳至主要内容
临床试验/NCT04402125
NCT04402125已完成不适用

Reducing Stroke Risk in African-American Men

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年5月5日最近更新:
适应症
干预措施

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

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

Experimental

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

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martha Sajatovic, MD

Professor

Case Western Reserve University

研究点 (2)

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