Clinical trial NCT04209985: Reaching for Equity in Sleep Apnea Treatment (REST) Study
Official title: Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Keywords: Health coaching
Adherence to treatment
Health disparities
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomly assigned to receive health coaching or usual care. Patients assigned to usual care have access to all existing 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. Patients in the health coaching arm have access to all usual care resources. In addition, they will be assigned an unlicensed, trained health coach who will call them 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 purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean number of hours used on average over the last 30 days
timeFrame: Enrollment to 4 months post enrollment
Secondary outcomes:
measure: Proportion using device at any time in last 30 days
timeFrame: Enrollment to 4 months post enrollment
measure: Patient-reported daytime sleepiness
timeFrame: Enrollment to 4 months post enrollment
measure: Attitudes to PAP treatment
timeFrame: Enrollment to 4 months post enrollment
measure: Confidence in using PAP therapy
timeFrame: Enrollment to 4 months post enrollment
measure: Mean number of hours used on average over the last 30 days on nights that device was used
timeFrame: Enrollment to 4 months post enrollment
measure: Mean proportion of last 30 days in which device used at least 4 hours/night
timeFrame: Enrollment to 4 months post enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital Sleep Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rachel Willard-Grace, MPH
role: PRINCIPAL_INVESTIGATOR
References: