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

A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00275340
Enrollment
101
Registered
2006-01-11
Start date
2006-02-28
Completion date
2007-04-30
Last updated
2009-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Pain, Depressive Symptoms, Coronary Artery Bypass, Convalescence, Quality of Life, Human Activities

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.

Interventions

OTHERPeer Support

Sponsors

Kingston Health Sciences Centre
CollaboratorOTHER
University of Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health-related Quality of Life (SF-36v2-acute Form)9 weeksThe 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

MeasureTime frame
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)9 weeks
Pain (McGill Pain Questionnaire-Short Form)9 weeks
Interference With Activities (Brief Pain Inventory-Interference Subscale)9 weeks
Function (Human Activity Profile)9 weeks

Countries

Canada

Participant flow

Recruitment details

Patients (n=106) were recruited between April-February 2007. Patients having elective coronary artery bypass graft surgery were recruited at the outpatient preadmission class; those having urgent/semi-urgent surgery were recruited in hospital. Peers (n=20) were recruited from the region of Southeastern Ontario during February-March 2006.

Pre-assignment details

One hundred and one patients were randomized at hospital discharge to either usual care or peer support. Five patients who were recruited preoperatively did not meet the eligibility criteria postoperatively for randomization. Of the 20 peers recruited, 6 were unable to participate in one of the training sessions offered in April 2006.

Participants by arm

ArmCount
Usual Care
Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
52
Peer Support
In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
49
Total101

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up24

Baseline characteristics

CharacteristicUsual CareTotalPeer Support
Age Continuous64 years
STANDARD_DEVIATION 10
64 years
STANDARD_DEVIATION 10
62 years
STANDARD_DEVIATION 11
Health-Related Quality of Life (SF-36v2-Acute Form)
Bodily Pain
64.4 units on a scale
STANDARD_DEVIATION 29
67.1 units on a scale
STANDARD_DEVIATION 27.7
70.4 units on a scale
STANDARD_DEVIATION 25.9
Health-Related Quality of Life (SF-36v2-Acute Form)
General Health
65.3 units on a scale
STANDARD_DEVIATION 18.8
64.6 units on a scale
STANDARD_DEVIATION 19.8
64.1 units on a scale
STANDARD_DEVIATION 21.5
Health-Related Quality of Life (SF-36v2-Acute Form)
Physical Component Score
41.2 units on a scale
STANDARD_DEVIATION 11
40.6 units on a scale
STANDARD_DEVIATION 11.1
40.5 units on a scale
STANDARD_DEVIATION 11.3
Health-Related Quality of Life (SF-36v2-Acute Form)
Physical Function
57.0 units on a scale
STANDARD_DEVIATION 27.7
54.7 units on a scale
STANDARD_DEVIATION 29.8
54.4 units on a scale
STANDARD_DEVIATION 31.7
Health-Related Quality of Life (SF-36v2-Acute Form)
Role-Physical
44.3 units on a scale
STANDARD_DEVIATION 32.4
40.3 units on a scale
STANDARD_DEVIATION 31.6
37.6 units on a scale
STANDARD_DEVIATION 30.8
Left Ventricular Function
Grade 1 (normal)
32 Participants52 Participants20 Participants
Left Ventricular Function
Grade 2
15 Participants39 Participants24 Participants
Left Ventricular Function
Grade 3
4 Participants9 Participants5 Participants
Left Ventricular Function
Grade 4 (worst)
0 Participants0 Participants0 Participants
Left Ventricular Function
No Response
1 Participants1 Participants0 Participants
Marital Status
Divorced/Widow/Single
13 participants20 participants7 participants
Marital Status
Married
38 participants80 participants42 participants
Marital Status
No Response
1 participants1 participants0 participants
Sex: Female, Male
Female
9 Participants17 Participants8 Participants
Sex: Female, Male
Male
43 Participants84 Participants41 Participants

Outcome results

Primary

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.

Time frame: 9 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareHealth-related Quality of Life (SF-36v2-acute Form)Role-Physical60.4 units on a scaleStandard Deviation 29.2
Usual CareHealth-related Quality of Life (SF-36v2-acute Form)General Health68.5 units on a scaleStandard Deviation 19.5
Usual CareHealth-related Quality of Life (SF-36v2-acute Form)Bodily Pain72.2 units on a scaleStandard Deviation 25.7
Usual CareHealth-related Quality of Life (SF-36v2-acute Form)Physical Component Summary Scale44.6 units on a scaleStandard Deviation 9.2
Usual CareHealth-related Quality of Life (SF-36v2-acute Form)Physical Functioning72.6 units on a scaleStandard Deviation 22
Peer SupportHealth-related Quality of Life (SF-36v2-acute Form)Physical Component Summary Scale47.5 units on a scaleStandard Deviation 8.2
Peer SupportHealth-related Quality of Life (SF-36v2-acute Form)Physical Functioning77.0 units on a scaleStandard Deviation 19
Peer SupportHealth-related Quality of Life (SF-36v2-acute Form)Role-Physical65.5 units on a scaleStandard Deviation 27.6
Peer SupportHealth-related Quality of Life (SF-36v2-acute Form)Bodily Pain78.8 units on a scaleStandard Deviation 21.5
Peer SupportHealth-related Quality of Life (SF-36v2-acute Form)General Health72.2 units on a scaleStandard Deviation 17.3
Comparison: Mean change scores were computed on domain and summary scores. Mean differences in change scores between groups were computed and t-tests used to detect significant differences.p-value: p<0t-test, 2 sided
Secondary

Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)

Time frame: 9 weeks

Secondary

Function (Human Activity Profile)

Time frame: 9 weeks

Secondary

Interference With Activities (Brief Pain Inventory-Interference Subscale)

Time frame: 9 weeks

Secondary

Pain (McGill Pain Questionnaire-Short Form)

Time frame: 9 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026