Trial Outcomes & Findings for CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence (NCT NCT02195531)
NCT ID: NCT02195531
Last Updated: 2019-04-05
Results Overview
Average usage hours per night
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
3 months
Results posted on
2019-04-05
Participant Flow
Participant milestones
| Measure |
Standard of Care
Participants will not receive education or feedback.
|
Treatment Group
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
49
|
56
|
|
Overall Study
COMPLETED
|
63
|
48
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care
Participants will not receive education or feedback.
|
Treatment Group
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
Baseline Characteristics
CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence
Baseline characteristics by cohort
| Measure |
Standard of Care
n=63 Participants
Participants will not receive education or feedback.
|
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
48 participants
n=7 Participants
|
55 participants
n=5 Participants
|
166 participants
n=4 Participants
|
|
Body Mass Index
|
34.5 kg/m^2
STANDARD_DEVIATION 8.2 • n=5 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
33.6 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
33.7 kg/m^2
STANDARD_DEVIATION 7.0 • n=4 Participants
|
|
Apnea-Hyopnea Index
|
32.7 events/hour
STANDARD_DEVIATION 17.9 • n=5 Participants
|
27.1 events/hour
STANDARD_DEVIATION 16.1 • n=7 Participants
|
28.2 events/hour
STANDARD_DEVIATION 16.2 • n=5 Participants
|
29.6 events/hour
STANDARD_DEVIATION 17.0 • n=4 Participants
|
|
Epworth Sleepiness Scale
|
11.1 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
10.9 units on a scale
STANDARD_DEVIATION 5.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsAverage usage hours per night
Outcome measures
| Measure |
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Standard of Care
n=63 Participants
Participants will not receive education or feedback.
|
|---|---|---|---|
|
Nightly Adherence
Week 1
|
4.83 hours
Standard Deviation 3.04
|
5.82 hours
Standard Deviation 3.08
|
4.82 hours
Standard Deviation 2.90
|
|
Nightly Adherence
Month 1
|
4.60 hours
Standard Deviation 3.09
|
4.96 hours
Standard Deviation 3.09
|
4.19 hours
Standard Deviation 3.05
|
|
Nightly Adherence
Month 2
|
4.32 hours
Standard Deviation 3.10
|
4.94 hours
Standard Deviation 3.08
|
3.60 hours
Standard Deviation 3.23
|
|
Nightly Adherence
Month 3
|
4.16 hours
Standard Deviation 3.18
|
4.63 hours
Standard Deviation 3.27
|
3.25 hours
Standard Deviation 3.27
|
PRIMARY outcome
Timeframe: 3 monthsAverage usage days per week.
Outcome measures
| Measure |
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Standard of Care
n=63 Participants
Participants will not receive education or feedback.
|
|---|---|---|---|
|
Adherence
|
5.5 days per week
Standard Deviation 2.1
|
5.8 days per week
Standard Deviation 1.7
|
4.9 days per week
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective. The average response for each questions was analyzed.
Outcome measures
| Measure |
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Standard of Care
n=63 Participants
Participants will not receive education or feedback.
|
|---|---|---|---|
|
Participant's Feedback on Educational Pamphlets - Expectations Scale
Screening
|
4.42 units on a scale
Standard Deviation 0.63
|
4.39 units on a scale
Standard Deviation 0.80
|
4.33 units on a scale
Standard Deviation 0.72
|
|
Participant's Feedback on Educational Pamphlets - Expectations Scale
Month 1
|
4.10 units on a scale
Standard Deviation 0.85
|
4.01 units on a scale
Standard Deviation 1.01
|
4.07 units on a scale
Standard Deviation 0.65
|
|
Participant's Feedback on Educational Pamphlets - Expectations Scale
Month 2
|
4.43 units on a scale
Standard Deviation 0.70
|
4.26 units on a scale
Standard Deviation 0.85
|
3.97 units on a scale
Standard Deviation 0.88
|
|
Participant's Feedback on Educational Pamphlets - Expectations Scale
Month 3
|
4.33 units on a scale
Standard Deviation 0.73
|
4.30 units on a scale
Standard Deviation 0.79
|
3.99 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important.
Outcome measures
| Measure |
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Standard of Care
n=63 Participants
Participants will not receive education or feedback.
|
|---|---|---|---|
|
Participant's Feedback on Educational Pamphlets - Importance Scale
Screening
|
4.69 units on a scale
Standard Deviation 0.59
|
4.58 units on a scale
Standard Deviation 0.71
|
4.65 units on a scale
Standard Deviation 0.65
|
|
Participant's Feedback on Educational Pamphlets - Importance Scale
Month 1
|
4.53 units on a scale
Standard Deviation 0.87
|
4.63 units on a scale
Standard Deviation 0.72
|
4.62 units on a scale
Standard Deviation 0.67
|
|
Participant's Feedback on Educational Pamphlets - Importance Scale
Month 2
|
4.65 units on a scale
Standard Deviation 0.65
|
4.66 units on a scale
Standard Deviation 0.71
|
4.36 units on a scale
Standard Deviation 0.82
|
|
Participant's Feedback on Educational Pamphlets - Importance Scale
Month 3
|
4.86 units on a scale
Standard Deviation 0.41
|
4.73 units on a scale
Standard Deviation 0.60
|
4.31 units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree. The average of each question was analyzed.
Outcome measures
| Measure |
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Standard of Care
n=63 Participants
Participants will not receive education or feedback.
|
|---|---|---|---|
|
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
Screening
|
4.49 units on a scale
Standard Deviation 0.53
|
4.20 units on a scale
Standard Deviation 0.84
|
4.29 units on a scale
Standard Deviation 0.73
|
|
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
Month 1
|
4.26 units on a scale
Standard Deviation 0.79
|
4.14 units on a scale
Standard Deviation 0.86
|
4.07 units on a scale
Standard Deviation 0.85
|
|
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
Month 2
|
4.29 units on a scale
Standard Deviation 0.76
|
4.42 units on a scale
Standard Deviation 0.81
|
4.14 units on a scale
Standard Deviation 1.00
|
|
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
Month 3
|
4.28 units on a scale
Standard Deviation 0.98
|
4.30 units on a scale
Standard Deviation 0.89
|
4.04 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much. The average of the questions were analyzed.
Outcome measures
| Measure |
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Standard of Care
n=63 Participants
Participants will not receive education or feedback.
|
|---|---|---|---|
|
Participant's Feedback on Educational Pamphlets - Motiviation
Month 1
|
9.10 units on a scale
Standard Deviation 1.35
|
8.82 units on a scale
Standard Deviation 1.75
|
8.85 units on a scale
Standard Deviation 1.47
|
|
Participant's Feedback on Educational Pamphlets - Motiviation
Month 3
|
9.11 units on a scale
Standard Deviation 1.23
|
8.98 units on a scale
Standard Deviation 1.81
|
8.57 units on a scale
Standard Deviation 1.83
|
|
Participant's Feedback on Educational Pamphlets - Motiviation
Screening
|
9.59 units on a scale
Standard Deviation 0.56
|
9.32 units on a scale
Standard Deviation 1.14
|
9.21 units on a scale
Standard Deviation 1.40
|
|
Participant's Feedback on Educational Pamphlets - Motiviation
Month 2
|
9.38 units on a scale
Standard Deviation 0.97
|
9.25 units on a scale
Standard Deviation 1.59
|
8.97 units on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree. The average of the scores were calculated and analyzed monthly.
Outcome measures
| Measure |
Treatment
n=48 Participants
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Control Group
n=55 Participants
Participants will receive education inconsistent with their profile.
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.
|
Standard of Care
Participants will not receive education or feedback.
|
|---|---|---|---|
|
Participant's Feedback on Educational Pamphlets - Leaflet Assessment
Screening
|
4.12 units on a scale
Standard Deviation 0.46
|
4.04 units on a scale
Standard Deviation 0.63
|
—
|
|
Participant's Feedback on Educational Pamphlets - Leaflet Assessment
Month 1
|
3.94 units on a scale
Standard Deviation 0.58
|
3.95 units on a scale
Standard Deviation 0.72
|
—
|
|
Participant's Feedback on Educational Pamphlets - Leaflet Assessment
Month 2
|
4.07 units on a scale
Standard Deviation 0.74
|
3.99 units on a scale
Standard Deviation 0.73
|
—
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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