Trial Outcomes & Findings for Health Coaching to Improve Self-Management in Thoracic Transplant Candidates (NCT NCT03150095)
NCT ID: NCT03150095
Last Updated: 2022-12-21
Results Overview
The 30 Item Self-Management Ability Scale (SMAS-30) measures self-management based on questions from 6 subsets of Taking Initiatives, Investment Behavior, Variety, Multifunctionality, Self-efficacy, and Positive Frame of Mind. These are totaled into a scale ranging from 0-100. Higher scores indicate better self-management ability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
12-16-week follow-up
Results posted on
2022-12-21
Participant Flow
Participant milestones
| Measure |
Health Coaching
Patients will work with a health coach to improve self-management skills
Health coaching: Patients will work with a health coach by telephone
|
Control
Patients will receive usual pre-transplant education to improve self-management skills
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
21
|
28
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Health Coaching
Patients will work with a health coach to improve self-management skills
Health coaching: Patients will work with a health coach by telephone
|
Control
Patients will receive usual pre-transplant education to improve self-management skills
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
unable or unwilling to continue health coaching
|
4
|
0
|
Baseline Characteristics
Health Coaching to Improve Self-Management in Thoracic Transplant Candidates
Baseline characteristics by cohort
| Measure |
Health Coaching
n=30 Participants
Patients will work with a health coach to improve self-management skills
Health coaching: Patients will work with a health coach by telephone
|
Control
n=30 Participants
Patients will receive usual pre-transplant education to improve self-management skills
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
55.97 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Score on Baseline Self-Management Ability Scale (SMAS-30)
|
70.31 score on a scale
STANDARD_DEVIATION 13.49 • n=5 Participants
|
70.74 score on a scale
STANDARD_DEVIATION 11.68 • n=7 Participants
|
70.53 score on a scale
STANDARD_DEVIATION 12.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12-16-week follow-upThe 30 Item Self-Management Ability Scale (SMAS-30) measures self-management based on questions from 6 subsets of Taking Initiatives, Investment Behavior, Variety, Multifunctionality, Self-efficacy, and Positive Frame of Mind. These are totaled into a scale ranging from 0-100. Higher scores indicate better self-management ability.
Outcome measures
| Measure |
Health Coaching
n=21 Participants
Patients will work with a health coach to improve self-management skills
Health coaching: Patients will work with a health coach by telephone
|
Control
n=28 Participants
Patients will receive usual pre-transplant education to improve self-management skills
|
|---|---|---|
|
Score on Follow-up Self-Management Ability Scale (SMAS-30)
|
75.06 score on a scale
Standard Deviation 17.01
|
71.47 score on a scale
Standard Deviation 11.09
|
Adverse Events
Health Coaching
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Health Coaching
n=30 participants at risk
Patients will work with a health coach to improve self-management skills
Health coaching: Patients will work with a health coach by telephone
|
Control
n=30 participants at risk
Patients will receive usual pre-transplant education to improve self-management skills
|
|---|---|---|
|
Surgical and medical procedures
Unplanned Hospital Admission
|
3.3%
1/30 • Number of events 1 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
|
Social circumstances
Fatal Automobile Accident
|
0.00%
0/30 • 16 weeks
|
3.3%
1/30 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Health Coaching
n=30 participants at risk
Patients will work with a health coach to improve self-management skills
Health coaching: Patients will work with a health coach by telephone
|
Control
n=30 participants at risk
Patients will receive usual pre-transplant education to improve self-management skills
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms
|
3.3%
1/30 • Number of events 1 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place