NCT02204449

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 22, 2015

Completed
Last Updated

December 30, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

July 28, 2014

Results QC Date

June 3, 2015

Last Update Submit

November 30, 2015

Conditions

Keywords

cardiac rehabilitationpeer mentorshiphealthcare utilizationcontinuity of cardiac care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cardiac Rehabilitation Referral

    12 weeks after patient has been discharged from hospital

Other Outcomes (1)

  • Cardiac Rehabilitation Enrollment in Site Closer to Home

    8 weeks after patient is discharged from hospital

Study Arms (2)

Cardiac Rehabilitation Peer Mentorship

EXPERIMENTAL

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.

Behavioral: Cardiac Rehabilitation Peer Mentorship

Usual Care

NO INTERVENTION

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.

Interventions

Cardiac Rehabilitation Peer Mentorship

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (1)

  • Ali-Faisal SF, Benz Scott L, Johnston L, Grace SL. Cardiac rehabilitation referral and enrolment across an academic health sciences centre with eReferral and peer navigation: a randomised controlled pilot trial. BMJ Open. 2016 Mar 21;6(3):e010214. doi: 10.1136/bmjopen-2015-010214.

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Results Point of Contact

Title
Dr. Sherry Grace
Organization
UHN Toronto

Study Officials

  • Sherry Grace, PhD

    York University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 30, 2015

Results First Posted

June 22, 2015

Record last verified: 2015-11

Locations