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Health Coaching for Positive Airway Pressure Adherence

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health coaching
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Francisco General Hospital Sleep Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health coaching arm

Usual care arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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)
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

Full Information

First Posted
August 21, 2019
Last Updated
August 22, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04067128
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health coaching arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
Brief telephonic intervention consisting of up to three phone calls
Primary Outcome Measure Information:
Title
Proportion using device at any time in last 30 days
Description
Numerator: Number of people using device at any time in last 30 days; Denominator: Number of people in study arm
Time Frame
Enrollment to 30 days post enrollment
Secondary Outcome Measure Information:
Title
Mean number of hours used on average over the last 30 days
Description
Total number of hours device used during 30 day period divided by 30 days
Time Frame
Enrollment to 30 days post enrollment
Title
Mean number of hours used on average over the last 30 days on nights that device was used
Description
Total number of hours device used during 30 day period divided by the number of days on which the device was used
Time Frame
Enrollment to 30 days post enrollment
Title
Mean proportion of last 30 days in which device used at least 4 hours/night
Description
Mean across group of: (Numerator: Number of days in last 30 days that device was used at least 4 hours; Denominator: 30 days)
Time Frame
Enrollment to 30 days post enrollment
Title
Proportion meeting Medicare standard for adherence (at least 4 hours/night for at least 70% of last 30 days)
Description
Numerator: Number of people meeting Medicare standard for adherence; Denominator: Number of people in study arm
Time Frame
Enrollment to 30 days post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
San Francisco General Hospital Sleep Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Health Coaching for Positive Airway Pressure Adherence

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