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

This study has been completed.
Sponsor:
Collaborator:
Kingston General Hospital
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00275340
First received: January 10, 2006
Last updated: June 5, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Other: Peer Support
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Health-Related Quality of Life (SF-36v2-Acute Form) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain (McGill Pain Questionnaire-Short Form) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Interference With Activities (Brief Pain Inventory-Interference Subscale) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Function (Human Activity Profile) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Depressive Symptoms (Center for Epidemiologic Studies Depression Scale) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: February 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275340

Locations
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5T 1P8
Sponsors and Collaborators
University of Toronto
Kingston General Hospital
Investigators
Principal Investigator: Monica J. Parry, PhD Faculty of Nursing, University of Toronto
  More Information

No publications provided by University of Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monica Parry, RN, PhD, CCN(C), University of Toronto
ClinicalTrials.gov Identifier: NCT00275340     History of Changes
Other Study ID Numbers: 15880
Study First Received: January 10, 2006
Results First Received: January 28, 2009
Last Updated: June 5, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Pain
Depressive Symptoms
Coronary Artery Bypass
Convalescence
Quality of Life
Human Activities

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014