Health Coaching for Positive Airway Pressure Adherence

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067128
• Other study ID #: 17-23281
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Behavioral:
• Health coaching
Brief telephonic intervention consisting of up to three phone calls

Locations

Country	Name	City	State
United States	San Francisco General Hospital Sleep Clinic	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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