NCT01775228

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

December 29, 2012

Last Update Submit

January 23, 2013

Conditions

Cardiovascular Disease

Keywords

Depression, peer support, recovery, health services

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    12 weeks

Secondary Outcomes (3)

  • Perceptions of recovery

    6 and 12 weeks

  • Perceptions of social support

    6 and 12 weeks

  • Health services utilization

    6 and 12 weeks

Other Outcomes (1)

  • Perceptions of peer support

    12 weeks

Study Arms (2)

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.

Behavioral: Peer Support

Interventions

Peer SupportBEHAVIORAL

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.

Also known as: Social Support
Peer Support intervention

Eligibility Criteria

Age36 Years - 87 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sudbury Regional Hospital

Greater Sudbury, Ontario, P3E2C6, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, N2C6J5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4G 1R7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 15350230BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Kathryn King, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD

Study Record Dates

First Submitted

December 29, 2012

First Posted

January 24, 2013

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2009

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

CA(3)