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

NCT ID: NCT02538419

Last Updated: 2019-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-09-30

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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CPAP + Peer Support

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

CPAP + Individual Education

Intervention Type BEHAVIORAL

Interventions

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CPAP + Peer Support

Intervention Type BEHAVIORAL

CPAP + Individual Education

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susan Redline

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Redline, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2014P002326

Identifier Type: -

Identifier Source: org_study_id

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