Trial Outcomes & Findings for Tailored Intervention to Promote Positive Airway Pressure Adherence (NCT NCT01454830)
NCT ID: NCT01454830
Last Updated: 2016-11-23
Results Overview
Mean CPAP use, hrs/night
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
118 participants
Primary outcome timeframe
1 week
Results posted on
2016-11-23
Participant Flow
Recruitment period 12/2011 through 1/2014 Location type: clinical sleep center
Participant milestones
| Measure |
Tailored
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
57
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
31
|
27
|
Reasons for withdrawal
| Measure |
Tailored
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Post-allocation Exclude- AHI<10
|
18
|
12
|
|
Overall Study
Post-allocation Exclude-refused PAP
|
0
|
2
|
|
Overall Study
Post-allocation Exclude-other treatment
|
6
|
7
|
|
Overall Study
Withdrawal - no polysomnography
|
3
|
2
|
Baseline Characteristics
Tailored Intervention to Promote Positive Airway Pressure Adherence
Baseline characteristics by cohort
| Measure |
Tailored
n=30 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=30 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Body Mass Index, Continuous
|
37.0 kg/m2
STANDARD_DEVIATION 8.1 • n=5 Participants
|
39.0 kg/m2
STANDARD_DEVIATION 10.3 • n=7 Participants
|
38.0 kg/m2
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Marital Status, Categorical
Married
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Marital Status, Categorical
Single
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Marital Status, Categorical
Separated or Divorced
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Marital Status, Categorical
Widow(er)
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Daytime Sleepiness by Epworth Sleepiness Scale, Continuous
|
18.7 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
20.4 units on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Apnea-hypopnea Index (AHI), events/hr, Continuous
|
33.9 events/hour
STANDARD_DEVIATION 21.3 • n=5 Participants
|
38.0 events/hour
STANDARD_DEVIATION 28.8 • n=7 Participants
|
35.9 events/hour
STANDARD_DEVIATION 25.2 • n=5 Participants
|
|
Apnea-hypopnea Index (AHI), Categorical
Mild: 5-15 events/hr
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Apnea-hypopnea Index (AHI), Categorical
Moderate: >15-30 events/hr
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Apnea-hypopnea Index (AHI), Categorical
Severe: >30 events/hr
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekMean CPAP use, hrs/night
Outcome measures
| Measure |
Tailored
n=30 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=30 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Nightly CPAP Use
|
6.4 hours/night
Standard Deviation 2.01
|
5.8 hours/night
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: 1 monthMean CPAP use, hrs/night
Outcome measures
| Measure |
Tailored
n=30 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=30 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Nightly CPAP Use
|
5.1 hours/night
Standard Deviation 2.05
|
5.1 hours/night
Standard Deviation 1.66
|
PRIMARY outcome
Timeframe: 3 monthsMean CPAP use, hrs/night
Outcome measures
| Measure |
Tailored
n=30 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=30 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Nightly CPAP Use
|
4.8 hours/night
Standard Deviation 2.27
|
4.7 hours/night
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Randomized participants with complete primary outcome data and secondary outcome data (total sleep time) measured by concurrent wrist actigraphy during first week of PAP treatment
% of Total Sleep Time (TST) using CPAP
Outcome measures
| Measure |
Tailored
n=21 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=24 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Proportion of Sleep Time on CPAP
|
64.58 percentage of TST on PAP
Standard Deviation 12.99
|
65.73 percentage of TST on PAP
Standard Deviation 14.25
|
SECONDARY outcome
Timeframe: Duration of protocol periodPopulation: Considers only participant withdrawals, administrative withdrawals for incomplete protocol procedures due to attrition; does NOT include excluded by a priori determined exclusion criteria for protocol
Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT
Outcome measures
| Measure |
Tailored
n=61 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=57 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Proportion of Participants Who Complete Protocol After Allocation
|
88.5 percentage of participants
|
86 percentage of participants
|
SECONDARY outcome
Timeframe: Duration of protocol periodPopulation: Considers only participant withdrawals requested from study
Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT
Outcome measures
| Measure |
Tailored
n=61 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=57 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Proportion of Participants Who Withdrawal
|
6.56 percentage of participants
|
7.02 percentage of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Acceptability rating by participants allocated to "interview" at study termination and debriefing; self-reported rating for binary response to satisfaction with study experience (yes/no); reported as percentage responding "yes"; no data available for participants who withdrew or were excluded prior to 3-month visit.
Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study termination and debriefing (3 months)
Outcome measures
| Measure |
Tailored
n=9 Participants
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
|
Usual Care
n=8 Participants
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|---|---|---|
|
Acceptability of Study Intervention and Comparative Group
|
100 percentage of allocated responding "yes"
|
100 percentage of allocated responding "yes"
|
Adverse Events
Tailored
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual 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