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

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ClinicalTrials.gov Identifier: NCT04209985
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Behavioral: Health coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.
Behavioral: Health coaching
Brief telephonic intervention consisting of up to five phone calls from a health coach

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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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 ]
    Total number of hours device used during 30 day period divided by the number of days on which the device was used

  6. Mean proportion of last 30 days in which device used at least 4 hours/night [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209985


Contacts
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Contact: George Su, MD 628-206-8314 George.Su@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital Sleep Clinic Recruiting
San Francisco, California, United States, 94110
Contact: George Su, MD    628-206-8314    George.Su@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Rachel Willard-Grace, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04209985    
Other Study ID Numbers: 19-27249
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Health coaching
Adherence to treatment
Health disparities
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases