Cardiovascular DiseasesRePeATNCT05933655
Re-thinking the Role of Peers And Training Patients [RePeAT]
A study testing Peer Coach in people with Cardiovascular Diseases, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Peer Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Peer Coach
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer CoachBehavioural
Peer coaching session to support shared decision making among patient with limited health literacy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer Coach |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: patient-clinician office visit, approximately 1 week after the peer coaching session
Secondary outcomes (1)
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.
Measured: post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Sep 2021
- Primary completion31 Jan 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- . Patients will be randomized at a 1:1 ratio, stratified by the clinician.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mechelle Sanders, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933655
- Sponsor's protocol ID
- 18638
- Other IDs
- K01HL159046
- Acronym
- RePeAT
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-thinking the Role of Peers And Training Patients [RePeAT]
- ClinicalTrials.gov ID
- NCT05933655
- Acronym / sponsor ID
- RePeAT / 18638
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- . Patients will be randomized at a 1:1 ratio, stratified by the clinician.
| Arm | Type | Receives |
|---|---|---|
| Peer Coach | Experimental | Behavioral: Peer CoachThe 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. |
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer CoachPeer coaching session to support shared decision making among patient with limited health literacy. | Behavioural | Peer Coach |
Primary outcome
ABCS Discussion
Time frame: 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.
1 secondary outcome
Peer Coach Fidelity
Time frame: post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Coach in people with Cardiovascular Diseases, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABCS Discussion (time frame: patient-clinician office visit, approximately 1 week after the peer coaching session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.