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

Cardiovascular Disease Clinical Trial

Official title:

The Effect of a Professionally-guided Telephone Peer Support Intervention on

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775228
• Other study ID #: 17897
• Secondary ID: UofC 17897
• Status: Completed
• Phase: N/A
• First received: December 29, 2012
• Last updated: January 23, 2013
• Start date: November 2006
• Est. completion date: November 2009

Study information

• Verified date: January 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 36 Years to 87 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Sudbury Regional Hospital	Sudbury	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Canadian Council of Cardiovascular Nurses, Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceptions of peer support	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	No
Primary	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	Yes
Primary	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	Yes
Secondary	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.	6 and 12 weeks	Yes
Secondary	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).	6 and 12 weeks	No
Secondary	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).	6 and 12 weeks	No