Percutaneous Coronary InterventionNCT02204449
Cardiac Rehabilitation Peer Mentorship
A study testing Cardiac Rehabilitation Peer Mentorship in people with Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, run by University Health Network, Toronto at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome
- What is being tested?
- Cardiac Rehabilitation Peer Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto General Hospital
Toronto, Ontario, M5G2C4
Toronto Western Hospital
Toronto, Ontario, M5T2S8
About this study
Official title: Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome, Chronic Stable Heart Failure, Coronary Artery Disease
- Being tested
- Cardiac Rehabilitation Peer Mentorship
- Keywords
- cardiac rehabilitation, peer mentorship, healthcare utilization, continuity of cardiac care
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation Peer MentorshipBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after patient is discharged from hospital
Secondary outcomes (1)
Cardiac Rehabilitation Referral
A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.
Measured: 12 weeks after patient has been discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Stony Brook University, York University
- Responsible party
- Principal investigator, Sherry Grace, York University
- Investigators
- Sherry Grace, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204449
- Sponsor's protocol ID
- 13-7183
- Status last verified
- Nov 2015
- First submitted
- 28 Jul 2014
- Last updated
- 30 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27000785
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02204449
- Acronym / sponsor ID
- 13-7183
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome, Chronic Stable Heart Failure, Coronary Artery Disease
- Keywords
- cardiac rehabilitation, peer mentorship, healthcare utilization, continuity of cardiac care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Stony Brook University, York University
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 22 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation Peer Mentorship | Experimental | Behavioral: Cardiac Rehabilitation Peer MentorshipTrained 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Cardiac Rehabilitation Peer Mentorship | Behavioural | Cardiac Rehabilitation Peer Mentorship |
Primary outcome
Cardiac Rehabilitation Enrollment
Time frame: 12 weeks after patient is discharged from hospital
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.
1 secondary outcome
Cardiac Rehabilitation Referral
Time frame: 12 weeks after patient has been discharged from hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27000785Ali-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.
Related trials for Percutaneous Coronary Intervention
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
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.
Sherry Grace, PhD principal investigator
York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation Peer Mentorship in people with Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, run by University Health Network, Toronto at 2 sites in Canada.
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 2 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 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiac Rehabilitation Enrollment (time frame: 12 weeks after patient is discharged from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204449, which also lists 1 linked publication.
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 30 Dec 2015.