Adherence
Conditions
Keywords
Adherence
Brief summary
The study hypothesis: in groups receiving tailored education and feedback in a style that matches their psychological profile, will show a higher CPAP adherence rates than groups receiving mismatched tailored education / feedback, and groups that receive no tailored education and feedback (standard of care).
Detailed description
Three group, randomized, controlled clinical trial assessing the extent to which tailoring a CPAP intervention entailing education and feedback to the psychological profile of new CPAP users can enhance the impact of the intervention in terms of adherence-related behavior.
Interventions
BEHAVIORALEducation and feedback
The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males or females, ages 21-80 years * Prescribed to start CPAP treatment and diagnosed with mild to severe OSA. * Recently (within study period) diagnosed with Mild to Severe OSA defined as an Apnea-Hypopnea Index of equal to or greater than 10 events per hour of sleep. * CPAP treatment naïve
Exclusion criteria
* Inability to provide informed consent * Presence of a comorbid condition that may potentially complicate CPAP adherence, such as: * Unstable depressive disorder * Unstable anxiety disorder * Dementia * Unable to understand study information * Obesity Hypoventilation Syndrome * Central Sleep Apnea or Complex Sleep Apnea * Facial musculoskeletal disorder * Unwillingness or inability to use CPAP therapy * Unable to return for follow up appointment * Use of supplemental oxygen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nightly Adherence | 3 months | Average usage hours per night |
| Adherence | 3 months | Average usage days per week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | 3 months | 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. |
| Participant's Feedback on Educational Pamphlets - Expectations Scale | 3 months | 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. |
| Participant's Feedback on Educational Pamphlets - Leaflet Assessment | 2 months | 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. |
| Participant's Feedback on Educational Pamphlets - Motiviation | 3 months | 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. |
| Participant's Feedback on Educational Pamphlets - Importance Scale | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Participants will not receive education or feedback. | 63 |
| Treatment 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. | 48 |
| 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. | 55 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Treatment | Total | Control Group | Standard of Care |
|---|---|---|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 10.9 | 50.5 years STANDARD_DEVIATION 12.4 | 53.3 years STANDARD_DEVIATION 12.8 | 48.0 years STANDARD_DEVIATION 12.5 |
| Apnea-Hyopnea Index | 27.1 events/hour STANDARD_DEVIATION 16.1 | 29.6 events/hour STANDARD_DEVIATION 17 | 28.2 events/hour STANDARD_DEVIATION 16.2 | 32.7 events/hour STANDARD_DEVIATION 17.9 |
| Body Mass Index | 32.8 kg/m^2 STANDARD_DEVIATION 5.6 | 33.7 kg/m^2 STANDARD_DEVIATION 7 | 33.6 kg/m^2 STANDARD_DEVIATION 6.5 | 34.5 kg/m^2 STANDARD_DEVIATION 8.2 |
| Epworth Sleepiness Scale | 10.4 units on a scale STANDARD_DEVIATION 5.3 | 10.9 units on a scale STANDARD_DEVIATION 5.5 | 11.2 units on a scale STANDARD_DEVIATION 5.6 | 11.1 units on a scale STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 48 participants | 166 participants | 55 participants | 63 participants |
| Sex: Female, Male Female | 14 Participants | 54 Participants | 17 Participants | 23 Participants |
| Sex: Female, Male Male | 34 Participants | 112 Participants | 38 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 55 | 0 / 63 |
| serious Total, serious adverse events | 0 / 48 | 0 / 55 | 0 / 63 |
Outcome results
Primary
Adherence
Average usage days per week.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Adherence | 5.5 days per week | Standard Deviation 2.1 |
| Control Group | Adherence | 5.8 days per week | Standard Deviation 1.7 |
| Standard of Care | Adherence | 4.9 days per week | Standard Deviation 2.5 |
Primary
Nightly Adherence
Average usage hours per night
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Nightly Adherence | Week 1 | 4.83 hours | Standard Deviation 3.04 |
| Treatment | Nightly Adherence | Month 1 | 4.60 hours | Standard Deviation 3.09 |
| Treatment | Nightly Adherence | Month 2 | 4.32 hours | Standard Deviation 3.1 |
| Treatment | Nightly Adherence | Month 3 | 4.16 hours | Standard Deviation 3.18 |
| Control Group | Nightly Adherence | Month 3 | 4.63 hours | Standard Deviation 3.27 |
| Control Group | Nightly Adherence | Week 1 | 5.82 hours | Standard Deviation 3.08 |
| Control Group | Nightly Adherence | Month 2 | 4.94 hours | Standard Deviation 3.08 |
| Control Group | Nightly Adherence | Month 1 | 4.96 hours | Standard Deviation 3.09 |
| Standard of Care | Nightly Adherence | Month 3 | 3.25 hours | Standard Deviation 3.27 |
| Standard of Care | Nightly Adherence | Month 1 | 4.19 hours | Standard Deviation 3.05 |
| Standard of Care | Nightly Adherence | Month 2 | 3.60 hours | Standard Deviation 3.23 |
| Standard of Care | Nightly Adherence | Week 1 | 4.82 hours | Standard Deviation 2.9 |
Secondary
Participant's Feedback on Educational Pamphlets - Expectations Scale
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.
Time frame: 3 months
Population: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Participant's Feedback on Educational Pamphlets - Expectations Scale | Screening | 4.42 units on a scale | Standard Deviation 0.63 |
| Treatment | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 1 | 4.10 units on a scale | Standard Deviation 0.85 |
| Treatment | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 2 | 4.43 units on a scale | Standard Deviation 0.7 |
| Treatment | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 3 | 4.33 units on a scale | Standard Deviation 0.73 |
| Control Group | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 3 | 4.30 units on a scale | Standard Deviation 0.79 |
| Control Group | Participant's Feedback on Educational Pamphlets - Expectations Scale | Screening | 4.39 units on a scale | Standard Deviation 0.8 |
| Control Group | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 2 | 4.26 units on a scale | Standard Deviation 0.85 |
| Control Group | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 1 | 4.01 units on a scale | Standard Deviation 1.01 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 3 | 3.99 units on a scale | Standard Deviation 1.03 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 1 | 4.07 units on a scale | Standard Deviation 0.65 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Expectations Scale | Month 2 | 3.97 units on a scale | Standard Deviation 0.88 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Expectations Scale | Screening | 4.33 units on a scale | Standard Deviation 0.72 |
Secondary
Participant's Feedback on Educational Pamphlets - Importance Scale
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.
Time frame: 3 months
Population: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 1 | 4.53 units on a scale | Standard Deviation 0.87 |
| Treatment | Participant's Feedback on Educational Pamphlets - Importance Scale | Screening | 4.69 units on a scale | Standard Deviation 0.59 |
| Treatment | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 2 | 4.65 units on a scale | Standard Deviation 0.65 |
| Treatment | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 3 | 4.86 units on a scale | Standard Deviation 0.41 |
| Control Group | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 3 | 4.73 units on a scale | Standard Deviation 0.6 |
| Control Group | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 2 | 4.66 units on a scale | Standard Deviation 0.71 |
| Control Group | Participant's Feedback on Educational Pamphlets - Importance Scale | Screening | 4.58 units on a scale | Standard Deviation 0.71 |
| Control Group | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 1 | 4.63 units on a scale | Standard Deviation 0.72 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Importance Scale | Screening | 4.65 units on a scale | Standard Deviation 0.65 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 1 | 4.62 units on a scale | Standard Deviation 0.67 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 2 | 4.36 units on a scale | Standard Deviation 0.82 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Importance Scale | Month 3 | 4.31 units on a scale | Standard Deviation 0.99 |
Secondary
Participant's Feedback on Educational Pamphlets - Leaflet Assessment
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.
Time frame: 2 months
Population: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Screening | 4.12 units on a scale | Standard Deviation 0.46 |
| Treatment | Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Month 1 | 3.94 units on a scale | Standard Deviation 0.58 |
| Treatment | Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Month 2 | 4.07 units on a scale | Standard Deviation 0.74 |
| Control Group | Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Screening | 4.04 units on a scale | Standard Deviation 0.63 |
| Control Group | Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Month 1 | 3.95 units on a scale | Standard Deviation 0.72 |
| Control Group | Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Month 2 | 3.99 units on a scale | Standard Deviation 0.73 |
Secondary
Participant's Feedback on Educational Pamphlets - Motiviation
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.
Time frame: 3 months
Population: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Participant's Feedback on Educational Pamphlets - Motiviation | Screening | 9.59 units on a scale | Standard Deviation 0.56 |
| Treatment | Participant's Feedback on Educational Pamphlets - Motiviation | Month 1 | 9.10 units on a scale | Standard Deviation 1.35 |
| Treatment | Participant's Feedback on Educational Pamphlets - Motiviation | Month 2 | 9.38 units on a scale | Standard Deviation 0.97 |
| Treatment | Participant's Feedback on Educational Pamphlets - Motiviation | Month 3 | 9.11 units on a scale | Standard Deviation 1.23 |
| Control Group | Participant's Feedback on Educational Pamphlets - Motiviation | Month 3 | 8.98 units on a scale | Standard Deviation 1.81 |
| Control Group | Participant's Feedback on Educational Pamphlets - Motiviation | Screening | 9.32 units on a scale | Standard Deviation 1.14 |
| Control Group | Participant's Feedback on Educational Pamphlets - Motiviation | Month 2 | 9.25 units on a scale | Standard Deviation 1.59 |
| Control Group | Participant's Feedback on Educational Pamphlets - Motiviation | Month 1 | 8.82 units on a scale | Standard Deviation 1.75 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Motiviation | Month 3 | 8.57 units on a scale | Standard Deviation 1.83 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Motiviation | Month 1 | 8.85 units on a scale | Standard Deviation 1.47 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Motiviation | Month 2 | 8.97 units on a scale | Standard Deviation 1.57 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Motiviation | Screening | 9.21 units on a scale | Standard Deviation 1.4 |
Secondary
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
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.
Time frame: 3 months
Population: As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Screening | 4.49 units on a scale | Standard Deviation 0.53 |
| Treatment | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 1 | 4.26 units on a scale | Standard Deviation 0.79 |
| Treatment | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 2 | 4.29 units on a scale | Standard Deviation 0.76 |
| Treatment | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 3 | 4.28 units on a scale | Standard Deviation 0.98 |
| Control Group | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 3 | 4.30 units on a scale | Standard Deviation 0.89 |
| Control Group | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Screening | 4.20 units on a scale | Standard Deviation 0.84 |
| Control Group | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 2 | 4.42 units on a scale | Standard Deviation 0.81 |
| Control Group | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 1 | 4.14 units on a scale | Standard Deviation 0.86 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 3 | 4.04 units on a scale | Standard Deviation 1.08 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 1 | 4.07 units on a scale | Standard Deviation 0.85 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Month 2 | 4.14 units on a scale | Standard Deviation 1 |
| Standard of Care | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Screening | 4.29 units on a scale | Standard Deviation 0.73 |