Cardiac Rehabilitation Peer Mentorship

Coronary Artery Disease Clinical Trial

Official title:

Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204449
• Other study ID #: 13-7183
• Status: Completed
• Phase: N/A
• First received: July 28, 2014
• Last updated: November 30, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship from a volunteer cardiac rehabilitation peer mentor, and a control group, in which they will receive usual care. Patients in both groups will be tracked to determine if they are referred to cardiac rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac rehabilitation.

Description:

The current study will be a randomized controlled trial in which cardiac inpatients will be randomized to either receive the intervention (cardiac rehabilitation peer mentorship) or be in the control group (receive usual care). After consent is obtained cardiac patients in the intervention group will be visited, at the hospital bedside, by trained volunteer cardiac rehabilitation peer mentors (i.e., individuals who have completed cardiac rehabilitation) who will provide the patients with information on cardiac rehabilitation as well as encourage the patients to obtain a referral from their healthcare provider. During this visit the cardiac rehabilitation peer mentor will also obtain agreement from the patient to call the patient at home two weeks after their discharge. Those in the control group will not be visited by cardiac rehabilitation peer mentors.

One week after discharge the cardiac rehabilitation peer mentors will mail the patients in the intervention a get-well soon card reminding the patient of the visit, giving them more information about the cardiac rehabilitation program, and reminding them of their future scheduled phone call. Two weeks after patients' discharge cardiac rehabilitation peer mentors will call the patients in the intervention group. At this point they will assess how the patient is doing, if they were referred to cardiac rehabilitation and if they enrolled. Any possible barriers the patients have to attending cardiac rehabilitation will also be discussed.

Eight weeks post-discharge, patient referral and enrolment will be ascertained by a research assistant blinded to random assignment. Statistical analyses will be conducted to determine any differences between the two groups as well as to determine any differences between men and women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any condition indicated for cardiac rehabilitation: Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft +/- valve surgery or procedure (e.g., TAVI), heart transplant, ventricular assist device, heart failure, arrhythmia, rhythm device (i.e. implantable cardioverter-defibrillator, cardiac resynchronization therapy, pacemaker), congenital heart disease, minor non-disabling stroke or transient ischemic attack (i.e., can ambulate), peripheral vascular disease

• Proficiency in English language

Exclusion Criteria:

• Any musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric condition, or any serious or terminal illness not otherwise specified which would preclude CR eligibility based on CR guidelines

• Being discharged to long-term care

• Inability to ambulate (i.e. walk unaided at 2mph)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chronic Stable Heart Failure
• Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Behavioral:
• Cardiac Rehabilitation Peer Mentorship

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Stony Brook University, York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac Rehabilitation Enrollment in Site Closer to Home	A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.	8 weeks after patient is discharged from hospital	No
Primary	Cardiac Rehabilitation Enrollment	A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.	12 weeks after patient is discharged from hospital	No
Secondary	Cardiac Rehabilitation Referral	A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.	12 weeks after patient has been discharged from hospital	No