- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02204449
Cardiac Rehabilitation Peer Mentorship
Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T2S8
- Toronto Western Hospital
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Toronto, Ontario, Canada, M5G2C4
- Toronto General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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, and arrange a time to call the patient/participant at home to find out about their CR progress.
One week post-discharge the peer mentor will mail a card to the patient to remind them of the planned call.
Two weeks post-discharge the peer mentor will call the patient at home to determine if they were referred and if they are planning to attend CR.
If any barriers are stated by patient the peer mentors will work with the patient to develop possible solutions.
Patients can request up to two additional phone calls from the mentors.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Rehabilitation Enrollment
Time Frame: 12 weeks after patient is discharged from hospital
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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.
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12 weeks after patient is discharged from hospital
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Rehabilitation Referral
Time Frame: 12 weeks after patient has been discharged from hospital
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A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.
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12 weeks after patient has been discharged from hospital
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Rehabilitation Enrollment in Site Closer to Home
Time Frame: 8 weeks after patient is discharged from hospital
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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.
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8 weeks after patient is discharged from hospital
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Collaborators and Investigators
Investigators
- Principal Investigator: Sherry Grace, PhD, York University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-7183
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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