Reaching for Equity in Sleep Apnea Treatment (REST) Study

Study Overview
=================
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.

Official Title
-----------------
Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Health coaching


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health coaching arm<br>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. | Behavioral: Health coaching<br>* Brief telephonic intervention consisting of up to five phone calls from a health coach<br>|
| No Intervention: Usual care<br>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 | 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 | 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 | 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 | 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) | Enrollment to 4 months post enrollment | 
| Confidence in using PAP therapy | 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 | 
| Mean number of hours used on average over the last 30 days on nights that device was used | 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 | 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) | Enrollment to 4 months post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health coaching, Adherence to treatment, Health disparities