Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
March 21, 2019
CompletedMarch 21, 2019
March 1, 2019
11 months
August 31, 2015
May 25, 2017
March 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence
Objective adherence to CPAP, measured in hours per night.
6 weeks
Secondary Outcomes (5)
Percentage of Participants With Adherence >=4 Hours/Night on Average
6 weeks
FOSQ
6 weeks
SEMSA - Perceived Risk
6 weeks
SEMSA - Outcome Expectations
6 weeks
SEMSA - Self Efficacy
6 weeks
Study Arms (2)
CPAP + Peer Support
ACTIVE COMPARATORParticipants 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
ACTIVE COMPARATORParticipants randomized to this arm will receive individual support and education from a trained investigator. All participants will receive CPAP in addition to this intervention.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with obstructive sleep apnea (no cut-off for severity)
- Prescribed continuous positive airway pressure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jessie Bakker
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Redline, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 2, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
March 21, 2019
Results First Posted
March 21, 2019
Record last verified: 2019-03