Cardiac Rehabilitation Peer Mentorship

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Health Network, Toronto
Sponsor:
Collaborators:
Stony Brook University
York University
Information provided by (Responsible Party):
Sherry Grace, York University
ClinicalTrials.gov Identifier:
NCT02204449
First received: July 28, 2014
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery
Acute Coronary Syndrome
Chronic Stable Heart Failure
Coronary Artery Disease
Behavioral: Cardiac Rehabilitation Peer Mentorship

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Cardiac rehabilitation enrollment [ Time Frame: 8 weeks after patient is discharged from hospital ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cardiac rehabilitation referral [ Time Frame: 8 weeks after patient has been discharged from hospital ] [ Designated as safety issue: No ]
    A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.


Other Outcome Measures:
  • Cardiac rehabilitation enrollment in site closer to home [ Time Frame: 8 weeks after patient is discharged from hospital ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 248
Study Start Date: July 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac Rehabilitation Peer Mentorship

Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.

One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.

Behavioral: Cardiac Rehabilitation Peer Mentorship
No Intervention: Usual Care
Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02204449

Contacts
Contact: Sobia F Ali-Faisal, PhD 416.603.5800 ext 3495 sobia.ali-faisal@uhnresearch.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G2C4
Contact: Sobia F Ali-Faisal, PhD    416-603-5800 ext 3495    sobia.ali-faisal@uhnresearch.ca   
Principal Investigator: Sherry Grace, PhD         
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Sobia F Ali-Faisal, PhD    416-603-5800 ext 3495    sobia.ali-faisal@uhnresearch.ca   
Principal Investigator: Sherry Grace, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Stony Brook University
York University
Investigators
Principal Investigator: Sherry Grace, PhD York University
  More Information

No publications provided

Responsible Party: Sherry Grace, Full Professor, York University
ClinicalTrials.gov Identifier: NCT02204449     History of Changes
Other Study ID Numbers: 13-7183
Study First Received: July 28, 2014
Last Updated: July 29, 2014
Health Authority: Canada: Institutional Review Board

Keywords provided by University Health Network, Toronto:
cardiac rehabilitation
peer mentorship
healthcare utilization
continuity of cardiac care

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Heart Failure
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014