Health Coaching for Positive Airway Pressure Adherence

Pilot of Brief Health Coaching Intervention to Improve Adherence to Positive Airway Pressure Therapy: Retroactive Analysis of a Quality Improvement Project

This study tested a low-resource, brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of sleep apnea.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Behavioral: Health coaching

Detailed Description

We conducted post hoc analysis of a quality improvement initiative in which patients were randomly assigned to receive health coaching or usual care. Participants were English- and Spanish-speaking patients from a county-based public health system who had previously received a positive airway pressure device for the treatment of sleep apnea. An unlicensed, trained health coach called patients three times to resolve barriers to adherence. Adherence measures collected by device modem at baseline and 4 weeks were the primary outcome measures.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital Sleep Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health coaching arm; For the health coaching arm, an unlicensed, trained health coach called patients three 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 three phone calls
No Intervention: Usual care arm; Patients assigned to usual care had 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
Proportion using device at any time in last 30 days	Numerator: Number of people using device at any time in last 30 days; Denominator: Number of people in study arm	Enrollment to 30 days post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of hours used on average over the last 30 days	Total number of hours device used during 30 day period divided by 30 days	Enrollment to 30 days 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 30 days 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 device was used at least 4 hours; Denominator: 30 days)	Enrollment to 30 days post enrollment
Proportion meeting Medicare standard for adherence (at least 4 hours/night for at least 70% of last 30 days)	Numerator: Number of people meeting Medicare standard for adherence; Denominator: Number of people in study arm	Enrollment to 30 days post enrollment

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: 17-23281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No