Clinical trial NCT04067128: Health Coaching for Positive Airway Pressure Adherence
Official title: Pilot of Brief Health Coaching Intervention to Improve Adherence to Positive Airway Pressure Therapy: Retroactive Analysis of a Quality Improvement Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

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
* 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

Primary outcomes:
measure: Proportion using device at any time in last 30 days
timeFrame: Enrollment to 30 days post enrollment
Secondary outcomes:
measure: Mean number of hours used on average over the last 30 days
timeFrame: Enrollment to 30 days post enrollment
measure: Mean number of hours used on average over the last 30 days on nights that device was used
timeFrame: Enrollment to 30 days post enrollment
measure: Mean proportion of last 30 days in which device used at least 4 hours/night
timeFrame: Enrollment to 30 days post enrollment
measure: Proportion meeting Medicare standard for adherence (at least 4 hours/night for at least 70% of last 30 days)
timeFrame: Enrollment to 30 days post enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital Sleep Clinic
state: California
Study officials:
References: