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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Behavioral: CPAP + Peer Support; Behavioral: CPAP + Individual Education

• Registration Number: NCT02538419
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-02
• Study Start: 2015-10
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2017-05-25
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Results First Posted: 2019-03-21
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP + Peer Support	CPAP + Peer Support	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.
CPAP + Individual Education	CPAP + Individual Education	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.

Primary Outcome Measures

Name	Time	Method
Adherence	6 weeks	Objective adherence to CPAP, measured in hours per night.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States