Effect of Peer Support Intervention on Early Recovery Outcomes Post Coronary Artery Bypass Graft Surgery

This study has been completed.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Canadian Council of Cardiovascular Nurses
Information provided by (Responsible Party):
Tracey JF Colella, University of Calgary
ClinicalTrials.gov Identifier:
NCT01775228
First received: December 29, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Behavioral: Peer Support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: The Effect of a Professionally-guided Telephone Peer Support Intervention on

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Post operative depression [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Perceptions of recovery [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Perceptions of social support [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Health services utilization [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Perceptions of peer support [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 185
Study Start Date: November 2006
Study Completion Date: November 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
Behavioral: Peer 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.
Other Name: Social Support

  Eligibility

Ages Eligible for Study:   36 Years to 87 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775228

Locations
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, N2C6J5
Sudbury Regional Hospital
Sudbury, Ontario, Canada, P3E2C6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4G 1R7
Sponsors and Collaborators
University of Calgary
Heart and Stroke Foundation of Canada
Canadian Council of Cardiovascular Nurses
Investigators
Principal Investigator: Kathryn King, PhD University of Calgary
  More Information

Publications:
Responsible Party: Tracey JF Colella, RN, PhD, University of Calgary
ClinicalTrials.gov Identifier: NCT01775228     History of Changes
Other Study ID Numbers: 17897, UofC 17897
Study First Received: December 29, 2012
Last Updated: January 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Depression, peer support, recovery, health services

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014