Coronary Artery DiseasePhase 1NCT00275340
Cardiac Home Education and Support Trial (CHEST): A Pilot Study
A Phase 1 study testing Peer Support in people with Coronary Artery Disease, run by University of Toronto at 1 site in Canada.
Trial summary
Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Peer Support
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2006to Apr 2007
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- are having first-time non-emergency CABG surgery
- are judged ready for discharge
- are being discharged to home [either their own or to family/friends]
- have access to and are able to communicate over a telephone
- are able to read, write and understand English
- have undergone CABG surgery within the last 5 years
Show all 10Show fewer
- have access to and are able to communicate clearly over a telephone
- are able to read, write and understand English
- have attended a formal cardiac rehabilitation program
- are not associated with the current in-hospital peer volunteer program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery
Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Individuals experience pain, functional impairment and depressive symptoms following discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional decline and depressive symptoms predispose individuals to adverse events, impaired health-related quality of life (HRQOL), and increased morbidity and mortality.
Existing supports; including printed education materials, community care resources, cardiac rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of individuals in this early period following hospital discharge.
Despite the positive health outcomes in other patient populations, valid studies examining the impact of telephone-based peer support to men and women after hospital discharge from CABG surgery were not found. It is anticipated that a home-based peer support program, delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early weeks post hospital discharge from CABG surgery.
Read the detailed description
Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. This, combined with reduced hospital length of stays, leaves individuals ill prepared for their recovery after discharge. Individuals experience pain, functional impairment and depressive symptoms; which predispose them to adverse events and impaired health-related quality of life (HRQOL). A home-based peer support program may improve recovery outcomes for individuals following CABG surgery.
The objectives of this pilot trial were to test the feasibility of all procedures, specifically to determine: 1) an estimate of patient and peer recruitment rates, 2) peer compliance and dose of the intervention, 3) peer satisfaction with orientation, 4) peer support activities offered to patients, and 5) patients' satisfaction with peer support. Additionally, exploratory research questions were used to determine indicators of the effects of peer support on HRQOL, pain, pain-related interference with activities, function, depressive symptoms, and enrolment in cardiac rehabilitation. An 8-week pre-post test RCT design enrolled men and women undergoing CABG surgery at a single site in Southeastern Ontario. Patients were randomized to either a usual care or an intervention group. Patients allocated to usual care received preoperative/postoperative education sessions, a preoperative video/information booklet, and preoperative/postoperative visits from in-hospital peer volunteers. In addition to usual care, patients in the intervention group received individualized education and support via telephone for 8 weeks following hospital discharge from trained peer volunteers.
Peer volunteers participated in a 4-hour orientation session. Ninety-three percent of the peers felt adequately prepared for their peer volunteer role and 98% of them initiated calls within 72 hours of the patient's discharge. Peers made an average of 12 calls, less than 30 minutes in duration, to each patient over the 8-week period. Most common support activities provided by the peers included listening to patient concerns, promoting activities, reinforcing rest periods and encouraging achievements. Patients were satisfied with their peer support experience. The intervention group reported improved physical function, role function, less pain and improved cardiac rehabilitation enrolment.
The evidence obtained from this pilot trial suggests that a home-based peer support intervention is feasible following CABG surgery. The information will be used to plan a larger multi-centre trial.
- Conditions
- Coronary Artery Disease
- Being tested
- Peer Support
- Keywords
- Pain, Depressive Symptoms, Coronary Artery Bypass, Convalescence, Quality of Life, Human Activities
- Medical subject headings
- Coronary Artery Disease, Pain, Depression, Convalescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer SupportOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life (SF-36v2-acute Form)
The SF-36v2 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.
Measured: 9 weeks
Secondary outcomes (4)
Pain (McGill Pain Questionnaire-Short Form)
Measured: 9 weeks
Interference With Activities (Brief Pain Inventory-Interference Subscale)
Measured: 9 weeks
Function (Human Activity Profile)
Measured: 9 weeks
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2007
- Study completionApr 2007
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 (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre
- Investigators
- Monica J. Parry, PhD, Principal investigator, Faculty of Nursing, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275340
- Sponsor's protocol ID
- 15880
- Status last verified
- Apr 2009
- First submitted
- 10 Jan 2006
- Last updated
- 8 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Parry M, Arthur H, Brooks D, Groll D, Pavlov A. Measuring function in older adults with co-morbid illnesses who are undergoing coronary artery bypass graft (CABG) surgery. Arch Gerontol Geriatr. 2012 May-Jun;54(3):477-83. doi: 10.1016/j.archger.2011.04.013. Epub 2011 Jun 29.
PubMed 21719124Parry MJ, Watt-Watson J, Hodnett E, Tranmer J, Dennis CL, Brooks D. Cardiac Home Education and Support Trial (CHEST): a pilot study. Can J Cardiol. 2009 Dec;25(12):e393-8. doi: 10.1016/s0828-282x(09)70531-8.
PubMed 19960132
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT00275340
- Acronym / sponsor ID
- 15880
- Conditions
- Coronary Artery Disease
- Keywords
- Pain, Depressive Symptoms, Coronary Artery Bypass, Convalescence, Quality of Life, Human Activities
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre
- Study start
- Feb 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Posted 8 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Individuals experience pain, functional impairment and depressive symptoms following discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional decline and depressive symptoms predispose individuals to adverse events, impaired health-related quality of life (HRQOL), and increased morbidity and mortality.
Existing supports; including printed education materials, community care resources, cardiac rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of individuals in this early period following hospital discharge.
Despite the positive health outcomes in other patient populations, valid studies examining the impact of telephone-based peer support to men and women after hospital discharge from CABG surgery were not found. It is anticipated that a home-based peer support program, delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early weeks post hospital discharge from CABG surgery.
Detailed description
Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. This, combined with reduced hospital length of stays, leaves individuals ill prepared for their recovery after discharge. Individuals experience pain, functional impairment and depressive symptoms; which predispose them to adverse events and impaired health-related quality of life (HRQOL). A home-based peer support program may improve recovery outcomes for individuals following CABG surgery.
The objectives of this pilot trial were to test the feasibility of all procedures, specifically to determine: 1) an estimate of patient and peer recruitment rates, 2) peer compliance and dose of the intervention, 3) peer satisfaction with orientation, 4) peer support activities offered to patients, and 5) patients' satisfaction with peer support. Additionally, exploratory research questions were used to determine indicators of the effects of peer support on HRQOL, pain, pain-related interference with activities, function, depressive symptoms, and enrolment in cardiac rehabilitation. An 8-week pre-post test RCT design enrolled men and women undergoing CABG surgery at a single site in Southeastern Ontario. Patients were randomized to either a usual care or an intervention group. Patients allocated to usual care received preoperative/postoperative education sessions, a preoperative video/information booklet, and preoperative/postoperative visits from in-hospital peer volunteers. In addition to usual care, patients in the intervention group received individualized education and support via telephone for 8 weeks following hospital discharge from trained peer volunteers.
Peer volunteers participated in a 4-hour orientation session. Ninety-three percent of the peers felt adequately prepared for their peer volunteer role and 98% of them initiated calls within 72 hours of the patient's discharge. Peers made an average of 12 calls, less than 30 minutes in duration, to each patient over the 8-week period. Most common support activities provided by the peers included listening to patient concerns, promoting activities, reinforcing rest periods and encouraging achievements. Patients were satisfied with their peer support experience. The intervention group reported improved physical function, role function, less pain and improved cardiac rehabilitation enrolment.
The evidence obtained from this pilot trial suggests that a home-based peer support intervention is feasible following CABG surgery. The information will be used to plan a larger multi-centre trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- are having first-time non-emergency CABG surgery
- are judged ready for discharge
- are being discharged to home [either their own or to family/friends]
- have access to and are able to communicate over a telephone
- are able to read, write and understand English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Peer Support | Other | – |
Primary outcome
Health-related Quality of Life (SF-36v2-acute Form)
Time frame: 9 weeks
The SF-36v2 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.
4 secondary outcomes
Pain (McGill Pain Questionnaire-Short Form)
Time frame: 9 weeks
Interference With Activities (Brief Pain Inventory-Interference Subscale)
Time frame: 9 weeks
Function (Human Activity Profile)
Time frame: 9 weeks
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21719124Parry M, Arthur H, Brooks D, Groll D, Pavlov A. Measuring function in older adults with co-morbid illnesses who are undergoing coronary artery bypass graft (CABG) surgery. Arch Gerontol Geriatr. 2012 May-Jun;54(3):477-83. doi: 10.1016/j.archger.2011.04.013. Epub 2011 Jun 29.
- Derived from this study: PubMed 19960132Parry MJ, Watt-Watson J, Hodnett E, Tranmer J, Dennis CL, Brooks D. Cardiac Home Education and Support Trial (CHEST): a pilot study. Can J Cardiol. 2009 Dec;25(12):e393-8. doi: 10.1016/s0828-282x(09)70531-8.
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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.
Monica J. Parry, PhD principal investigator
Faculty of Nursing, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peer Support in people with Coronary Artery Disease, run by University of Toronto at 1 site 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 10 inclusion and 0 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 8 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2009). 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?
Health-related Quality of Life (SF-36v2-acute Form) (time frame: 9 weeks). 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 NCT00275340, which also lists 2 linked publications.
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 8 Jun 2009.