- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04209985
Reaching for Equity in Sleep Apnea Treatment (REST) Study (REST pilot)
May 15, 2023 updated by: University of California, San Francisco
Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment
This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.
Study Overview
Detailed Description
The investigators will carry out a pilot study in which patients will be randomly assigned to receive health coaching or usual care.
Participants are English- and Spanish-speaking patients from a county-based public health system who have received a positive airway pressure device for the treatment of sleep apnea.
An unlicensed, trained health coach will call patients three times to resolve barriers to adherence.
Primary outcomes include both adherence measures collected by the device modem at baseline and 4 months, and patient-reported outcomes such as daytime sleepiness.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: George Su, MD
- Phone Number: 628-206-8314
- Email: George.Su@ucsf.edu
Study Locations
-
-
California
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San Francisco, California, United States, 94110
- Recruiting
- Zuckerberg San Francisco General Hospital Sleep Clinic
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Contact:
- George Su, MD
- Phone Number: 628-206-8314
- Email: George.Su@ucsf.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- English- or Spanish-speaking
- At least 18 years of age
- Had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea
- Not currently meeting Medicare standards for adherence of at least 4 hours per night for at least 70% of the last 30 nights
- Received care from the San Francisco General Hospital Sleep Clinic
Exclusion Criteria:
- Not English- or Spanish-speaking
- Younger than 18 years
- Does not have phone number at which could be reached
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health coaching arm
For the health coaching arm, an unlicensed, trained health coach will call patients up to five times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers.
|
Brief telephonic intervention consisting of up to five phone calls from a health coach
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No Intervention: Usual care
Patients assigned to usual care have access to all other available resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean number of hours used on average over the last 30 days
Time Frame: Enrollment to 4 months post enrollment
|
Total number of hours PAP device used during 30 day period divided by 30 days (PAP device is part of existing clinical care)
|
Enrollment to 4 months post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion using device at any time in last 30 days
Time Frame: Enrollment to 4 months post enrollment
|
Numerator: Number of people using PAP device at any time in last 30 days; Denominator: Number of people in study arm (PAP device is part of existing clinical care)
|
Enrollment to 4 months post enrollment
|
Patient-reported daytime sleepiness
Time Frame: Enrollment to 4 months post enrollment
|
Mean score on the Epworth Sleepiness Scale (8 items with aggregate scale of 0-24 points, where 24 indicates greatest sleepiness symptoms)
|
Enrollment to 4 months post enrollment
|
Attitudes to PAP treatment
Time Frame: Enrollment to 4 months post enrollment
|
Mean score on the Attitudes to PAP Treatment Inventory (5 items with combined scale of 4-25, where higher scores indicate negative attitudes toward PAP treatment)
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Enrollment to 4 months post enrollment
|
Confidence in using PAP therapy
Time Frame: Enrollment to 4 months post enrollment
|
Mean score on self-efficacy for use of PAP therapy (4 items, with combined scale from 0-40, where 40 indicates greatest self-efficacy)
|
Enrollment to 4 months post enrollment
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Mean number of hours used on average over the last 30 days on nights that device was used
Time Frame: Enrollment to 4 months post enrollment
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Total number of hours device used during 30 day period divided by the number of days on which the device was used
|
Enrollment to 4 months post enrollment
|
Mean proportion of last 30 days in which device used at least 4 hours/night
Time Frame: Enrollment to 4 months post enrollment
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Mean across group of: (Numerator: Number of days in last 30 days that PAP device was used at least 4 hours; Denominator: 30 days) (PAP device is part of existing clinical care)
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Enrollment to 4 months post enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rachel Willard-Grace, MPH, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2020
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
December 20, 2019
First Submitted That Met QC Criteria
December 20, 2019
First Posted (Actual)
December 24, 2019
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-27249
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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