Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment

Study Overview
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Brief Summary
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The investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support administered in groups, versus individual education.

Detailed Description
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The study is a 6-week, open-label, parallel-arm, randomized controlled trial comparing peer support and individual education (the latter of which was designed to mimic usual care). Participants in the peer-support (intervention) arm will be encouraged to attend two peer-support sessions, with one session occurring immediately prior to beginning CPAP and the other occurring two weeks later. Participants in the individual education (comparator) arm will begin CPAP without attendance at any peer-support sessions.

Official Title
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Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Behavioral: CPAP + Peer Support
* Behavioral: CPAP + Individual Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with obstructive sleep apnea (no cut-off for severity) Prescribed continuous positive airway pressure Exclusion Criteria: Not fluent in English Prior CPAP use at home Current use of any non-CPAP treatment for obstructive sleep apnea A co-morbid sleep disorder Use of supplemental oxygen A clinical need for urgent CPAP therapy

Ages Eligible for Study
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Minimum Age: 21 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP + Peer Support<br>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. All participants will receive CPAP in addition to this intervention. | Behavioral: CPAP + Peer Support<br> <br> |
| Active Comparator: CPAP + Individual Education<br>Participants randomized to this arm will receive individual support and education from a trained investigator. All participants will receive CPAP in addition to this intervention. | Behavioral: CPAP + Individual Education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Objective adherence to CPAP, measured in hours per night. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adherence >=4 Hours/Night on Average | Objective adherence to CPAP, percentage with adherence >=4 hours/night on average | 6 weeks | 
| FOSQ | Functional 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. | 6 weeks | 
| SEMSA - Perceived Risk | Self 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. | 6 weeks | 
| SEMSA - Outcome Expectations | Self 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. | 6 weeks | 
| SEMSA - Self Efficacy | Self 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. | 6 weeks |