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Cardiac Home Education and Support Trial (CHEST): A Pilot Study

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Peer Support
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Pain, Depressive Symptoms, Coronary Artery Bypass, Convalescence, Quality of Life, Human Activities

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (patients): Men and women who 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 Inclusion Criteria (peers): Men and women who 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

Sites / Locations

  • University of Toronto

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain (McGill Pain Questionnaire-Short Form)
Interference With Activities (Brief Pain Inventory-Interference Subscale)
Function (Human Activity Profile)
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)

Full Information

First Posted
January 10, 2006
Last Updated
June 5, 2009
Sponsor
University of Toronto
Collaborators
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00275340
Brief Title
Cardiac Home Education and Support Trial (CHEST): A Pilot Study
Official Title
A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. This, combined with reduced hospital length of stays, leaves individuals ill prepared for their recovery after discharge. Individuals experience pain, functional impairment and depressive symptoms; which predispose them to adverse events and impaired health-related quality of life (HRQOL). A home-based peer support program may improve recovery outcomes for individuals following CABG surgery. The objectives of this pilot trial were to test the feasibility of all procedures, specifically to determine: 1) an estimate of patient and peer recruitment rates, 2) peer compliance and dose of the intervention, 3) peer satisfaction with orientation, 4) peer support activities offered to patients, and 5) patients' satisfaction with peer support. Additionally, exploratory research questions were used to determine indicators of the effects of peer support on HRQOL, pain, pain-related interference with activities, function, depressive symptoms, and enrolment in cardiac rehabilitation. An 8-week pre-post test RCT design enrolled men and women undergoing CABG surgery at a single site in Southeastern Ontario. Patients were randomized to either a usual care or an intervention group. Patients allocated to usual care received preoperative/postoperative education sessions, a preoperative video/information booklet, and preoperative/postoperative visits from in-hospital peer volunteers. In addition to usual care, patients in the intervention group received individualized education and support via telephone for 8 weeks following hospital discharge from trained peer volunteers. Peer volunteers participated in a 4-hour orientation session. Ninety-three percent of the peers felt adequately prepared for their peer volunteer role and 98% of them initiated calls within 72 hours of the patient's discharge. Peers made an average of 12 calls, less than 30 minutes in duration, to each patient over the 8-week period. Most common support activities provided by the peers included listening to patient concerns, promoting activities, reinforcing rest periods and encouraging achievements. Patients were satisfied with their peer support experience. The intervention group reported improved physical function, role function, less pain and improved cardiac rehabilitation enrolment. The evidence obtained from this pilot trial suggests that a home-based peer support intervention is feasible following CABG surgery. The information will be used to plan a larger multi-centre trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Pain, Depressive Symptoms, Coronary Artery Bypass, Convalescence, Quality of Life, Human Activities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Peer Support
Primary Outcome Measure Information:
Title
Health-related Quality of Life (SF-36v2-acute Form)
Description
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.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Pain (McGill Pain Questionnaire-Short Form)
Time Frame
9 weeks
Title
Interference With Activities (Brief Pain Inventory-Interference Subscale)
Time Frame
9 weeks
Title
Function (Human Activity Profile)
Time Frame
9 weeks
Title
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)
Time Frame
9 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (patients): Men and women who 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 Inclusion Criteria (peers): Men and women who 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica J. Parry, PhD
Organizational Affiliation
Faculty of Nursing, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1P8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21719124
Citation
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.
Results Reference
derived
PubMed Identifier
19960132
Citation
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.
Results Reference
derived

Learn more about this trial

Cardiac Home Education and Support Trial (CHEST): A Pilot Study

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