Reaching for Equity in Sleep Apnea Treatment (REST) Study
- Conditions
- Sleep Apnea
- Interventions
- Behavioral: Health coaching
- Registration Number
- NCT04209985
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Not English- or Spanish-speaking
- Younger than 18 years
- Does not have phone number at which could be reached
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health coaching arm Health coaching 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.
- Primary Outcome Measures
Name Time Method Mean number of hours used on average over the last 30 days 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)
- Secondary Outcome Measures
Name Time Method Attitudes to PAP treatment 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)
Proportion using device at any time in last 30 days 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)
Patient-reported daytime sleepiness 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)
Confidence in using PAP therapy 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)
Mean number of hours used on average over the last 30 days on nights that device was used Enrollment to 4 months post enrollment Total number of hours device used during 30 day period divided by the number of days on which the device was used
Mean proportion of last 30 days in which device used at least 4 hours/night Enrollment to 4 months post enrollment 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)
Trial Locations
- Locations (1)
Zuckerberg San Francisco General Hospital Sleep Clinic
🇺🇸San Francisco, California, United States