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临床试验/NCT05933655
NCT05933655已完成不适用

Re-thinking the Role of Peers And Training Patients [RePeAT]

University of Rochester1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月1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
60
试验地点
1
主要终点
ABCS Discussion

研究概览

简要总结

This study, Re-thinking the role of Peers And Training Patients [RePeAT], is designed to test the feasibility of training peer-coaches to prepare limited health literacy (LHL) patients to engage in shared-decision making (SDM) for cardiovascular disease (CVD) risk-reduction.

详细描述

The investigators will use a 2-arm pilot RCT design to assess the feasibility, and acceptability of the intervention. Up to 60 primary care patients will be randomly assigned to participate in the peer-coaching or control group. Patients will be randomized at a 1:1 ratio, stratified by the clinician. Half of the subjects (n=30) will be assigned to the peer-coaching intervention, and the other half will be assigned to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

盲法说明

Immediately after subjects complete the baseline surveys they will be randomized. The research coordinator will open a sealed envelope that specifies which group the subject is in. Neither the subject nor the research coordinator can choose the randomization group. The randomizations envelopes will be prepared

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •A patient of Highland Family Medicine practice
  • •At least 40 years old and no more than 75 years old
  • •Be at ≥10% risk for CVD as calculated using the ASCVD Risk Estimator Plus
  • •No plans to leave the practice in the next 12 months
  • •English speaking
  • •Limited Health Literacy (self-report)

排除标准

  • •Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA) or have had a CVD procedure such as installation of a stent or angioplasty
  • •Gave peripheral vascular disease, intermittent claudication or peripheral arterial disease
  • •Lack of capacity to consent

研究组 & 干预措施

Peer Coach

Experimental

The research coordinator will set up a time for the subject to have a brief discussion with a peer coach from the study team approximately 1 week after randomization. During the coaching session, the peer coach will encourage the subject to mention their heart health goals to their primary care clinician during their next primary care appointment. The peer coach will also help the subject brainstorm ways to remove any barriers that may prevent them from having the discussion with their clinician. The peer coaching session and the subsequent medical appointment will be audio-recorded.

干预措施: Peer Coach (Behavioral)

Control

No Intervention

The subject will not be asked to meet with the peer coach or anyone from the study team prior to their next visit with their primary care clinician. Their subsequent primary care appointment will be audio-recorded.

结局指标

主要结局

ABCS Discussion

时间窗: patient-clinician office visit, approximately 1 week after the peer coaching session

The investigators will qualitatively code the office visit to determine if subjects engaged in a discussion with their clinician about their ABCS options/preferences.

次要结局

  • Peer Coach Fidelity(post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit)

研究者

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

Mechelle Sanders

Assistant Professor

University of Rochester

研究点 (1)

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