NCT00275340

Brief Summary

Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Individuals experience pain, functional impairment and depressive symptoms following discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional decline and depressive symptoms predispose individuals to adverse events, impaired health-related quality of life (HRQOL), and increased morbidity and mortality. Existing supports; including printed education materials, community care resources, cardiac rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of individuals in this early period following hospital discharge. Despite the positive health outcomes in other patient populations, valid studies examining the impact of telephone-based peer support to men and women after hospital discharge from CABG surgery were not found. It is anticipated that a home-based peer support program, delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early weeks post hospital discharge from CABG surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for phase_1 coronary-artery-disease

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 8, 2009

Completed
Last Updated

June 8, 2009

Status Verified

April 1, 2009

Enrollment Period

1.2 years

First QC Date

January 10, 2006

Results QC Date

January 28, 2009

Last Update Submit

June 5, 2009

Conditions

Coronary Artery Disease

Keywords

PainDepressive SymptomsCoronary Artery BypassConvalescenceQuality of LifeHuman Activities

Outcome Measures

Primary Outcomes (1)

  • Health-related Quality of Life (SF-36v2-acute Form)

    The SF-36v2 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.

    9 weeks

Secondary Outcomes (4)

  • Pain (McGill Pain Questionnaire-Short Form)

    9 weeks

  • Interference With Activities (Brief Pain Inventory-Interference Subscale)

    9 weeks

  • Function (Human Activity Profile)

    9 weeks

  • Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)

    9 weeks

Interventions

Peer SupportOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • are having first-time non-emergency CABG surgery
  • are judged ready for discharge
  • are being discharged to home \[either their own or to family/friends\]
  • have access to and are able to communicate over a telephone
  • are able to read, write and understand English
  • have undergone CABG surgery within the last 5 years
  • have access to and are able to communicate clearly over a telephone
  • are able to read, write and understand English
  • have attended a formal cardiac rehabilitation program
  • are not associated with the current in-hospital peer volunteer program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5T 1P8, Canada

Location

Related Publications (2)

  • Parry M, Arthur H, Brooks D, Groll D, Pavlov A. Measuring function in older adults with co-morbid illnesses who are undergoing coronary artery bypass graft (CABG) surgery. Arch Gerontol Geriatr. 2012 May-Jun;54(3):477-83. doi: 10.1016/j.archger.2011.04.013. Epub 2011 Jun 29.

    PMID: 21719124DERIVED

  • Parry MJ, Watt-Watson J, Hodnett E, Tranmer J, Dennis CL, Brooks D. Cardiac Home Education and Support Trial (CHEST): a pilot study. Can J Cardiol. 2009 Dec;25(12):e393-8. doi: 10.1016/s0828-282x(09)70531-8.

    PMID: 19960132DERIVED

MeSH Terms

Conditions

Coronary Artery DiseasePainDepressionConvalescence

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorDisease AttributesPathologic Processes

Results Point of Contact

Title
Monica Parry, RN, PhD, CCN(C)
Organization
University of Toronto
parrym@kgh.kari.net

Study Officials

  • Monica J. Parry, PhD

    Faculty of Nursing, University of Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

February 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

June 8, 2009

Results First Posted

June 8, 2009

Record last verified: 2009-04

Locations

CA(1)