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Completed

NCT Number: NCT04067128

Health Coaching for Positive Airway Pressure Adherence

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital Sleep Clinic

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Coaching

Behavioral

Brief telephonic intervention consisting of up to three phone calls

Primary outcomes

  1. Proportion using device at any time in last 30 days

    Time frame: Enrollment to 30 days post enrollment

    Numerator: Number of people using device at any time in last 30 days; Denominator: Number of people in study arm

Secondary outcomes

  1. Mean number of hours used on average over the last 30 days

    Time frame: Enrollment to 30 days post enrollment

    Total number of hours device used during 30 day period divided by 30 days

  2. Mean number of hours used on average over the last 30 days on nights that device was used

    Time frame: Enrollment to 30 days post enrollment

    Total number of hours device used during 30 day period divided by the number of days on which the device was used

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

    Time frame: Enrollment to 30 days post enrollment

    Mean across group of: (Numerator: Number of days in last 30 days that device was used at least 4 hours; Denominator: 30 days)

  4. Proportion meeting Medicare standard for adherence (at least 4 hours/night for at least 70% of last 30 days)

    Time frame: Enrollment to 30 days post enrollment

    Numerator: Number of people meeting Medicare standard for adherence; Denominator: Number of people in study arm

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 26, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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