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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538419
• Other study ID #: 2014P002326
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: March 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Behavioral:
• CPAP + Peer Support

• CPAP + Individual Education

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Objective adherence to CPAP, measured in hours per night.	6 weeks
Secondary	Percentage of Participants With Adherence >=4 Hours/Night on Average	Objective adherence to CPAP, percentage with adherence >=4 hours/night on average	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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