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

NCT ID: NCT05933655

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

. Patients will be randomized at a 1:1 ratio, stratified by the clinician.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
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

Study Groups

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Peer Coach

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.

Group Type EXPERIMENTAL

Peer Coach

Intervention Type BEHAVIORAL

Peer coaching session to support shared decision making among patient with limited health literacy.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peer Coach

Peer coaching session to support shared decision making among patient with limited health literacy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Mechelle Sanders

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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K01HL159046

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18638

Identifier Type: -

Identifier Source: org_study_id

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