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

Cardiovascular Diseases Clinical Trial

— RePeAT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05933655
• Other study ID #: 18638
• Secondary ID: K01HL159046
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Peer Coach
Peer coaching session to support shared decision making among patient with limited health literacy.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABCS Discussion	The investigators will qualitatively code the office visit to determine if subjects engaged in a discussion with their clinician about their ABCS options/preferences.	patient-clinician office visit, approximately 1 week after the peer coaching session
Secondary	Peer Coach Fidelity	The investigators will qualitatively code the peer coaching sessions to determine if peer coaches used Teach-back during their session and if the coaching session was done with fidelity.	post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit