Health Coaching for Positive Airway Pressure Adherence

NCT04067128 | Completed

• 1 other identifier: 17-23281
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean number of hours used on average over the last 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

  Enrollment to 30 days post enrollment

• Mean proportion of last 30 days in which device used at least 4 hours/night

  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)

  Enrollment to 30 days post enrollment

Study Arms (2)

Health coaching arm

EXPERIMENTAL

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

Usual care arm

NO INTERVENTION

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.

Interventions

Health coaching BEHAVIORAL

Brief telephonic intervention consisting of up to three phone calls

Health coaching arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not English- or Spanish-speaking
• Younger than 18 years
• Does not have phone number at which could be reached

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital Sleep Clinic

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients were randomly assigned to receive health coaching or usual care. 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. 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.

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: March 1, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)