Cardiovascular DiseaseNCT01775228
Effect of Peer Support Intervention on Early Recovery Outcomes Post Coronary Artery Bypass Graft Surgery
A study testing Peer Support in people with Cardiovascular Disease, run by University of Calgary at 3 sites in Canada.
Trial summary
Recovery from coronary artery bypass graft (CABG) surgery is a complex process involving physical recuperation and psychological adjustment. The high prevalence of postoperative depression in this population may threaten optimal recovery. Peer support over the recovery period has promise to mitigate this threat. Read more about this study
- Who is it for?
- Ages 36 to 87 years, men only
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2006to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 36 to 87 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- > 35 years of age
- undergoing first-time traditional (sternotomy approach) CABG surgery
- an uncomplicated postoperative course
- standard length of hospital stay (four to eight days)
- had a telephone in the home
- able to hear telephone conversation.
Who cannot join
- had cardiac surgery procedures other than CABG surgery
- resided in a nursing home or long term care facility
- had any neurological or psychiatric disorder that may have impeded ability to self reflect or communicate
- had emergent cardiac surgery
- had sustained in-hospital post surgical complications of major significance (i.e., stroke, GI bleed, cardiac tamponade, renal failure, cardiac arrest, major sepsis of any origin, deep sternal wound infection, myocardial infarction with significant hemodynamic compromise)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Sudbury Regional Hospital
Greater Sudbury, Ontario, P3E2C6
Southlake Regional Health Centre
Newmarket, Ontario, N2C6J5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4G 1R7
About this study
Official title: The Effect of a Professionally-guided Telephone Peer Support Intervention on
Recovery from coronary artery bypass graft (CABG) surgery is a complex process involving physical recuperation and psychological adjustment. The high prevalence of postoperative depression in this population may threaten optimal recovery. Peer support over the recovery period has promise to mitigate this threat. The purpose of this study was to examine the effect of a professionally-guided telephone peer support intervention on recovery outcomes including depression, social support and health care resource utilization.
In a randomized controlled trial, 185 male CABG surgery patients randomly assigned to an intervention (n=61) or usual care (n=124) group. Participants in the intervention group received weekly telephone calls from a peer volunteer over 6 weeks post discharge. At hospital discharge and at 6 and 12 weeks follow up, depression was measured using the Beck Depression Scale-II, social support was measured using the Shortened Social Support Scale and health care resource utilization was measured using items in the Postoperative Self Report of Recovery Questionnaire. Participants in the intervention group were also asked questions about their perceptions regarding peer support using the Peer Support Evaluation Inventory.
- Conditions
- Cardiovascular Disease
- Being tested
- Peer Support
- Keywords
- Depression, peer support, recovery, health services
- Medical subject headings
- Cardiovascular Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer SupportBehavioural
Also called Social Support
Support (informational, emotional and appraisal) in the form of like persons (i.e. age, gender) who have undergone CABG surgery with successful outcomes (post-recovery at least one year); peer support was provided by telephone for 6 weeks post cardiac surgery recovery.
| Study group | Role | What they receive |
|---|---|---|
| Regular follow up care | No intervention | No intervention group - received routine follow up care following discharge from hospital after cardiac surgery (no peer support intervention). |
| Peer Support intervention | Active comparator | Support (informational, emotional and appraisal) in the form of like persons (i.e. age, gender) who have undergone CABG surgery with successful outcomes (post-recovery at least one year); peer support was provided by telephone for 6 weeks post cardiac surgery recovery. Receives: Behavioral: Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative depression
A disorder of mood characterized by sadness and loss of interest in usually satisfying activities, a negative view of the self and hopelessness, passivity, indecisiveness, suicidal ideations, loss of appetite, weight loss, sleep disturbances, and other physical symptoms. Some or all of these symptoms may be present, and depression can be categorized as mild, moderate, or severe/major according to scores measured on the Beck Depression Inventory II (BDI-II) (Diagnostic and Statistical Manual of Mental Health Disorders - Fourth Edition) (DSM-IV criteria).
Measured: 6 weeks
Post operative depression
A disorder of mood characterized by sadness and loss of interest in usually satisfying activities, a negative view of the self and hopelessness, passivity, indecisiveness, suicidal ideations, loss of appetite, weight loss, sleep disturbances, and other physical symptoms. Some or all of these symptoms may be present, and depression can be categorized as mild, moderate, or severe/major according to scores measured on the Beck Depression Inventory II (BDI-II) (Diagnostic and Statistical Manual of Mental Health Disorders - Fourth Edition) (DSM-IV criteria).
Measured: 12 weeks
Secondary outcomes (3)
Perceptions of recovery
Includes biophysical recovery, return to activity, and return to social roles; perceptions focused on the absence or resolution of physiological and/or psychosocial clinical symptoms. (Perceptions of recovery were measured by the Postoperative Self-Report of Recovery Questionnaire (PSRRQ) over 12-weeks post-discharge.
Measured: 6 and 12 weeks
Perceptions of social support
Resources provided by others that can take the form of emotional support, instrumental aid, information, and positive feedback as to one's importance, capabilities or self worth. Social support was measured using the Shortened Social Support Scale (SSSS).
Measured: 6 and 12 weeks
Health services utilization
The consumption of health services (emergency room visits, regularly scheduled and unscheduled family physician visits and readmission to hospital) to meet health care needs as defined by the patient or the health care professional. This was measured by the number of health care visits/readmissions to hospital over 12-weeks post-discharge using the Postoperative Self Report of Recovery (PSRRQ).
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Council of Cardiovascular Nurses
- Responsible party
- Principal investigator, Tracey JF Colella, University of Calgary
- Investigators
- Kathryn King, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775228
- Sponsor's protocol ID
- 17897
- Other IDs
- UofC 17897
- Status last verified
- Jan 2013
- First submitted
- 29 Dec 2012
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Colella TJ, King KM. Peer support. An under-recognized resource in cardiac recovery. Eur J Cardiovasc Nurs. 2004 Sep;3(3):211-7. doi: 10.1016/j.ejcnurse.2004.04.001.
PubMed 15350230
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Professionally-guided Telephone Peer Support Intervention on
- ClinicalTrials.gov ID
- NCT01775228
- Acronym / sponsor ID
- 17897
- Conditions
- Cardiovascular Disease
- Keywords
- Depression, peer support, recovery, health services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Council of Cardiovascular Nurses
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recovery from coronary artery bypass graft (CABG) surgery is a complex process involving physical recuperation and psychological adjustment. The high prevalence of postoperative depression in this population may threaten optimal recovery. Peer support over the recovery period has promise to mitigate this threat. The purpose of this study was to examine the effect of a professionally-guided telephone peer support intervention on recovery outcomes including depression, social support and health care resource utilization.
In a randomized controlled trial, 185 male CABG surgery patients randomly assigned to an intervention (n=61) or usual care (n=124) group. Participants in the intervention group received weekly telephone calls from a peer volunteer over 6 weeks post discharge. At hospital discharge and at 6 and 12 weeks follow up, depression was measured using the Beck Depression Scale-II, social support was measured using the Shortened Social Support Scale and health care resource utilization was measured using items in the Postoperative Self Report of Recovery Questionnaire. Participants in the intervention group were also asked questions about their perceptions regarding peer support using the Peer Support Evaluation Inventory.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular follow up care | No intervention | –No intervention group - received routine follow up care following discharge from hospital after cardiac surgery (no peer support intervention). |
| Peer Support intervention | Active comparator | Behavioral: Peer SupportSupport (informational, emotional and appraisal) in the form of like persons (i.e. age, gender) who have undergone CABG surgery with successful outcomes (post-recovery at least one year); peer support was provided by telephone for 6 weeks post cardiac surgery recovery. |
Who may qualify
- Ages
- 36 to 87 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- > 35 years of age
- undergoing first-time traditional (sternotomy approach) CABG surgery
- an uncomplicated postoperative course
- standard length of hospital stay (four to eight days)
Key exclusion criteria (5 listed)
- had cardiac surgery procedures other than CABG surgery
- resided in a nursing home or long term care facility
- had any neurological or psychiatric disorder that may have impeded ability to self reflect or communicate
- had emergent cardiac surgery
- had sustained in-hospital post surgical complications of major significance (i.e., stroke, GI bleed, cardiac tamponade, renal failure, cardiac arrest, major sepsis of any origin, deep sternal wound infection, myocardial infarction with significant hemodynamic compromise)
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 SupportAlso: Social SupportSupport (informational, emotional and appraisal) in the form of like persons (i.e. age, gender) who have undergone CABG surgery with successful outcomes (post-recovery at least one year); peer support was provided by telephone for 6 weeks post cardiac surgery recovery. | Behavioural | Peer Support intervention |
Primary outcome
Post operative depression
Time frame: 6 weeks
A disorder of mood characterized by sadness and loss of interest in usually satisfying activities, a negative view of the self and hopelessness, passivity, indecisiveness, suicidal ideations, loss of appetite, weight loss, sleep disturbances, and other physical symptoms. Some or all of these symptoms may be present, and depression can be categorized as mild, moderate, or severe/major according to scores measured on the Beck Depression Inventory II (BDI-II) (Diagnostic and Statistical Manual of Mental Health Disorders - Fourth Edition) (DSM-IV criteria).
Post operative depression
Time frame: 12 weeks
A disorder of mood characterized by sadness and loss of interest in usually satisfying activities, a negative view of the self and hopelessness, passivity, indecisiveness, suicidal ideations, loss of appetite, weight loss, sleep disturbances, and other physical symptoms. Some or all of these symptoms may be present, and depression can be categorized as mild, moderate, or severe/major according to scores measured on the Beck Depression Inventory II (BDI-II) (Diagnostic and Statistical Manual of Mental Health Disorders - Fourth Edition) (DSM-IV criteria).
3 secondary outcomes
Perceptions of recovery
Time frame: 6 and 12 weeks
Perceptions of social support
Time frame: 6 and 12 weeks
Health services utilization
Time frame: 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Background: PubMed 15350230Colella TJ, King KM. Peer support. An under-recognized resource in cardiac recovery. Eur J Cardiovasc Nurs. 2004 Sep;3(3):211-7. doi: 10.1016/j.ejcnurse.2004.04.001.
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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.
Kathryn King, PhD principal investigator
University of Calgary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support in people with Cardiovascular Disease, run by University of Calgary at 3 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 7 inclusion and 5 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post operative depression (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT01775228, 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 24 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.