CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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BIG4 - CPAP Educational Materials and Usage Feedback to Promote CPAP Adherence

Conditions
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Adherence

Intervention / Treatment
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* Behavioral: Education and feedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Participants will receive education and feedback tailored to the psychological profile of the receiving participant. | Behavioral: Education and feedback<br>* The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.<br>* Other names: Motivational Enhancement technique;|
| Active Comparator: Control Group<br>Participants will receive education inconsistent with their profile. | Behavioral: Education and feedback<br>* The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.<br>* Other names: Motivational Enhancement technique;|
| No Intervention: Standard of care<br>Participants will not receive education or feedback. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightly Adherence | Average usage hours per night | 3 months | 
| Adherence | Average usage days per week. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| 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. | 3 months | 
| 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. | 3 months | 
| 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. | 3 months | 
| 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. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence