Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP + Peer Support
CPAP + Individual Education
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Apnea, Obstructive
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CPAP + Peer Support
CPAP + Individual Education
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Adherence
Objective adherence to CPAP, measured in hours per night.
Secondary Outcome Measures
Percentage of Participants With Adherence >=4 Hours/Night on Average
Objective adherence to CPAP, percentage with adherence >=4 hours/night on average
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.
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.
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.
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.
Full Information
NCT ID
NCT02538419
First Posted
August 31, 2015
Last Updated
March 20, 2019
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02538419
Brief Title
Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
Official Title
Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP + Peer Support
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CPAP + Individual Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CPAP + Peer Support
Intervention Type
Behavioral
Intervention Name(s)
CPAP + Individual Education
Primary Outcome Measure Information:
Title
Adherence
Description
Objective adherence to CPAP, measured in hours per night.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adherence >=4 Hours/Night on Average
Description
Objective adherence to CPAP, percentage with adherence >=4 hours/night on average
Time Frame
6 weeks
Title
FOSQ
Description
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.
Time Frame
6 weeks
Title
SEMSA - Perceived Risk
Description
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.
Time Frame
6 weeks
Title
SEMSA - Outcome Expectations
Description
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.
Time Frame
6 weeks
Title
SEMSA - Self Efficacy
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Redline, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment
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