Trial Outcomes & Findings for Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment (NCT NCT02538419)
NCT ID: NCT02538419
Last Updated: 2019-03-21
Results Overview
Objective adherence to CPAP, measured in hours per night.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-03-21
Participant Flow
Participant milestones
| Measure |
Peer Support
Participants randomized to this arm will receive support from a 'Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants (intervention arm) missing data for 95th percentile pressure due to CPAP data-card error.
Baseline characteristics by cohort
| Measure |
Peer Support
n=20 Participants
Participants randomized to this arm will receive support from a 'Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
n=20 Participants
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 13.3 • n=20 Participants
|
50.4 years
STANDARD_DEVIATION 13.5 • n=20 Participants
|
49.9 years
STANDARD_DEVIATION 13.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Body mass index
|
32.3 kg/m^2
STANDARD_DEVIATION 5.3 • n=20 Participants
|
30.3 kg/m^2
STANDARD_DEVIATION 5.8 • n=20 Participants
|
31.3 kg/m^2
STANDARD_DEVIATION 6.0 • n=40 Participants
|
|
Underwent home sleep testing (as opposed to in-lab sleep testing)
|
16 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Apnea-hypopnea index
|
11.1 Events/hour
n=20 Participants
|
14.3 Events/hour
n=20 Participants
|
11.4 Events/hour
n=40 Participants
|
|
Oxygen saturation nadir
|
81.5 % of oxygen saturation
n=20 Participants
|
83.0 % of oxygen saturation
n=20 Participants
|
82.5 % of oxygen saturation
n=40 Participants
|
|
Pressure 95th percentile
|
11.4 cmH2O
n=18 Participants • Two participants (intervention arm) missing data for 95th percentile pressure due to CPAP data-card error.
|
10.7 cmH2O
n=20 Participants • Two participants (intervention arm) missing data for 95th percentile pressure due to CPAP data-card error.
|
10.9 cmH2O
n=38 Participants • Two participants (intervention arm) missing data for 95th percentile pressure due to CPAP data-card error.
|
|
Leak 95th percentile
|
17.7 liters/minute
n=18 Participants • Two participants (intervention arm) missing data for 95th percentile leak due to CPAP data-card error.
|
17.9 liters/minute
n=20 Participants • Two participants (intervention arm) missing data for 95th percentile leak due to CPAP data-card error.
|
17.7 liters/minute
n=38 Participants • Two participants (intervention arm) missing data for 95th percentile leak due to CPAP data-card error.
|
|
Residual apnea-hypopnea index
|
2.6 events/hour
n=18 Participants • Two participants (intervention arm) missing data for residual AHI due to CPAP data-card error.
|
2.3 events/hour
n=20 Participants • Two participants (intervention arm) missing data for residual AHI due to CPAP data-card error.
|
2.6 events/hour
n=38 Participants • Two participants (intervention arm) missing data for residual AHI due to CPAP data-card error.
|
|
Functional Outcomes of Sleep Questionnaire
|
16.2 units on a scale
STANDARD_DEVIATION 2.3 • n=20 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 3.3 • n=20 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 3.0 • n=40 Participants
|
|
Self Efficacy Measure for Sleep Apnea - Perceived Risk
|
1.5 units on a scale
STANDARD_DEVIATION 0.4 • n=20 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 0.4 • n=20 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 0.4 • n=40 Participants
|
|
Self Efficacy Measure for Sleep Apnea - Outcome Expectations
|
2.0 units on a scale
STANDARD_DEVIATION 0.4 • n=20 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.6 • n=20 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.5 • n=40 Participants
|
|
Self Efficacy Measure for Sleep Apnea - Self Efficacy
|
2.1 units on a scale
STANDARD_DEVIATION 0.5 • n=20 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.6 • n=20 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.6 • n=40 Participants
|
PRIMARY outcome
Timeframe: 6 weeksObjective adherence to CPAP, measured in hours per night.
Outcome measures
| Measure |
Peer Support
n=20 Participants
Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
n=20 Participants
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
|---|---|---|
|
Adherence
|
4.5 hours/night
Standard Deviation 2.1
|
5.0 hours/night
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 6 weeksObjective adherence to CPAP, percentage with adherence \>=4 hours/night on average
Outcome measures
| Measure |
Peer Support
n=20 Participants
Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
n=20 Participants
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
|---|---|---|
|
Percentage of Participants With Adherence >=4 Hours/Night on Average
|
65 percentage of participants
|
65 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksFunctional Outcomes of Sleep Questionnaire. The FOSQ is a questionnaire which allows the participant to describe their sleep quality, on a scale of 5 to 20. Higher scores indicate better sleep.
Outcome measures
| Measure |
Peer Support
n=20 Participants
Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
n=20 Participants
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
|---|---|---|
|
FOSQ
|
17.7 units on a scale
Standard Deviation 1.3
|
16.1 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6 weeksSelf Efficacy Measure for Sleep Apnea - Perceived Risk The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of perceived risk associated with sleep apnea.
Outcome measures
| Measure |
Peer Support
n=20 Participants
Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
n=20 Participants
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
|---|---|---|
|
SEMSA - Perceived Risk
|
1.6 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 6 weeksSelf Efficacy Measure for Sleep Apnea - Outcome Expectations. The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of outcome expectations associated with treatment of sleep apnea.
Outcome measures
| Measure |
Peer Support
n=20 Participants
Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
n=20 Participants
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
|---|---|---|
|
SEMSA - Outcome Expectations
|
2.2 units on a scale
Standard Deviation 0.8
|
2.3 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 6 weeksSelf Efficacy Measure for Sleep Apnea - Self Efficacy The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of self efficacy associated with treatment of sleep apnea.
Outcome measures
| Measure |
Peer Support
n=20 Participants
Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support
|
Individual Education
n=20 Participants
Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education
|
|---|---|---|
|
SEMSA - Self Efficacy
|
2.2 units on a scale
Standard Deviation 0.8
|
2.3 units on a scale
Standard Deviation 0.6
|
Adverse Events
Peer Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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