- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775228
Effect of Peer Support Intervention on Early Recovery Outcomes Post Coronary Artery Bypass Graft Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Newmarket, Ontario, Canada, N2C6J5
- Southlake Regional Health Centre
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Sudbury, Ontario, Canada, P3E2C6
- Sudbury Regional Hospital
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Toronto, Ontario, Canada, M4G 1R7
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Regular follow up care
No intervention group - received routine follow up care following discharge from hospital after cardiac surgery (no peer support intervention).
|
|
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Active Comparator: Peer Support intervention
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
6 weeks
|
|
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).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions of recovery
Time Frame: 6 and 12 weeks
|
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.
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6 and 12 weeks
|
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Perceptions of social support
Time Frame: 6 and 12 weeks
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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).
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6 and 12 weeks
|
|
Health services utilization
Time Frame: 6 and 12 weeks
|
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).
|
6 and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions of peer support
Time Frame: 12 weeks
|
Evaluation of the different aspects of peer support received (supportive interactions, relationship qualities, perceived benefits, satisfactions with support received) as measured by the Peer Support Evaluation Inventory (PSEI).
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathryn King, PhD, University of Calgary
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
- 17897
- UofC 17897 (Other Identifier: University of Calgary)
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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