Trial Outcomes & Findings for Cardiac Home Education and Support Trial (CHEST): A Pilot Study (NCT NCT00275340)
NCT ID: NCT00275340
Last Updated: 2009-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
101 participants
Primary outcome timeframe
9 weeks
Results posted on
2009-06-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
49
|
|
Overall Study
COMPLETED
|
50
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
Baseline Characteristics
Cardiac Home Education and Support Trial (CHEST): A Pilot Study
Baseline characteristics by cohort
| Measure |
Usual Care
n=52 Participants
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.
|
Peer Support
n=49 Participants
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.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
62 years
STANDARD_DEVIATION 11 • n=7 Participants
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Left Ventricular Function
Grade 1 (normal)
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Left Ventricular Function
Grade 2
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Left Ventricular Function
Grade 3
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Left Ventricular Function
Grade 4 (worst)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Left Ventricular Function
No Response
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital Status
Married
|
38 participants
n=5 Participants
|
42 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Marital Status
Divorced/Widow/Single
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Marital Status
No Response
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Health-Related Quality of Life (SF-36v2-Acute Form)
Physical Function
|
57.0 units on a scale
STANDARD_DEVIATION 27.7 • n=5 Participants
|
54.4 units on a scale
STANDARD_DEVIATION 31.7 • n=7 Participants
|
54.7 units on a scale
STANDARD_DEVIATION 29.8 • n=5 Participants
|
|
Health-Related Quality of Life (SF-36v2-Acute Form)
Role-Physical
|
44.3 units on a scale
STANDARD_DEVIATION 32.4 • n=5 Participants
|
37.6 units on a scale
STANDARD_DEVIATION 30.8 • n=7 Participants
|
40.3 units on a scale
STANDARD_DEVIATION 31.6 • n=5 Participants
|
|
Health-Related Quality of Life (SF-36v2-Acute Form)
Bodily Pain
|
64.4 units on a scale
STANDARD_DEVIATION 29.0 • n=5 Participants
|
70.4 units on a scale
STANDARD_DEVIATION 25.9 • n=7 Participants
|
67.1 units on a scale
STANDARD_DEVIATION 27.7 • n=5 Participants
|
|
Health-Related Quality of Life (SF-36v2-Acute Form)
General Health
|
65.3 units on a scale
STANDARD_DEVIATION 18.8 • n=5 Participants
|
64.1 units on a scale
STANDARD_DEVIATION 21.5 • n=7 Participants
|
64.6 units on a scale
STANDARD_DEVIATION 19.8 • n=5 Participants
|
|
Health-Related Quality of Life (SF-36v2-Acute Form)
Physical Component Score
|
41.2 units on a scale
STANDARD_DEVIATION 11.0 • n=5 Participants
|
40.5 units on a scale
STANDARD_DEVIATION 11.3 • n=7 Participants
|
40.6 units on a scale
STANDARD_DEVIATION 11.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Usual Care
n=50 Participants
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.
|
Peer Support
n=45 Participants
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.
|
|---|---|---|
|
Health-related Quality of Life (SF-36v2-acute Form)
Physical Functioning
|
72.6 units on a scale
Standard Deviation 22
|
77.0 units on a scale
Standard Deviation 19.0
|
|
Health-related Quality of Life (SF-36v2-acute Form)
Role-Physical
|
60.4 units on a scale
Standard Deviation 29.2
|
65.5 units on a scale
Standard Deviation 27.6
|
|
Health-related Quality of Life (SF-36v2-acute Form)
Bodily Pain
|
72.2 units on a scale
Standard Deviation 25.7
|
78.8 units on a scale
Standard Deviation 21.5
|
|
Health-related Quality of Life (SF-36v2-acute Form)
General Health
|
68.5 units on a scale
Standard Deviation 19.5
|
72.2 units on a scale
Standard Deviation 17.3
|
|
Health-related Quality of Life (SF-36v2-acute Form)
Physical Component Summary Scale
|
44.6 units on a scale
Standard Deviation 9.2
|
47.5 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 9 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 weeksOutcome measures
Outcome data not reported
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place