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Reaching for Equity in Sleep Apnea Treatment (REST) Study (REST pilot)

Primary Purpose

Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health coaching
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Apnea focused on measuring Health coaching, Adherence to treatment, Health disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zuckerberg San Francisco General Hospital Sleep ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health coaching arm

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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
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)

Full Information

First Posted
December 20, 2019
Last Updated
May 15, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04209985
Brief Title
Reaching for Equity in Sleep Apnea Treatment (REST) Study
Acronym
REST pilot
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
Health coaching, Adherence to treatment, Health disparities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health coaching arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
Brief telephonic intervention consisting of up to five phone calls from a health coach
Primary Outcome Measure Information:
Title
Mean number of hours used on average over the last 30 days
Description
Total number of hours PAP device used during 30 day period divided by 30 days (PAP device is part of existing clinical care)
Time Frame
Enrollment to 4 months post enrollment
Secondary Outcome Measure Information:
Title
Proportion using device at any time in last 30 days
Description
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)
Time Frame
Enrollment to 4 months post enrollment
Title
Patient-reported daytime sleepiness
Description
Mean score on the Epworth Sleepiness Scale (8 items with aggregate scale of 0-24 points, where 24 indicates greatest sleepiness symptoms)
Time Frame
Enrollment to 4 months post enrollment
Title
Attitudes to PAP treatment
Description
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)
Time Frame
Enrollment to 4 months post enrollment
Title
Confidence in using PAP therapy
Description
Mean score on self-efficacy for use of PAP therapy (4 items, with combined scale from 0-40, where 40 indicates greatest self-efficacy)
Time Frame
Enrollment to 4 months post enrollment
Title
Mean number of hours used on average over the last 30 days on nights that device was used
Description
Total number of hours device used during 30 day period divided by the number of days on which the device was used
Time Frame
Enrollment to 4 months post enrollment
Title
Mean proportion of last 30 days in which device used at least 4 hours/night
Description
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)
Time Frame
Enrollment to 4 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Su, MD
Phone
628-206-8314
Email
George.Su@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Willard-Grace, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital Sleep Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Su, MD
Phone
628-206-8314
Email
George.Su@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Reaching for Equity in Sleep Apnea Treatment (REST) Study

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