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Completed

NCT Number: NCT03243487

ThErapy Adherence Management in Veterans

The study is a prospective, randomized, controlled trial studying adherence to positive airway pressure therapy in a population referred to the VA system for the treatment of sleep disordered breathing. The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting Centers for Medicare & Medicaid Services (CMS) adherence requirements (use > 4 hours for >= 70% of days) at 90 days.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malcom Randall VA Medical Center, Gainesville, Florida, United States

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About this study

The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting CMS adherence requirements (use > 4hrs on >=70% of nights) at 90 days.

Secondary aims:

  • Results in higher nightly use of therapy (hours per night and % of nights with at least 4 hours of use) at 90 days
  • Results in participant satisfaction that is superior to current standard care
  • Offers operational efficiencies or economic benefits to the health care facility (reduced staff time (sleep clinic and physician), equipment consumption, unplanned participant contacts or visits, and reduced overtime)
  • Results in indirect benefits to participants (fewer clinic visits, less travel or in-clinic/ office visit waiting time)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 21 to 85
  • Diagnostic Apnoea-Hypopnoea Index (AHI) ≥ 15 determined by in lab polysomnography (PSG) or home sleep testing (HST) or by a sleep therapy device
  • Eligible for treatment with Automatically adjusted CPAP or Automatically adjusted BiPAP
  • Currently has a Smart Phone or home access (computer with internet access) to the internet based version of the software application

Exclusion criteria

  • Participation in another interventional research concerned with sleep disorders within the last 30 days
  • Major uncontrolled medical condition that would interfere with the demands of the study, adherence to PAP, or the ability to commit to follow-up assessment including conditions such as poorly managed or controlled or advanced stages of pulmonary disease, cardiac disease, neurological disease, neuromuscular disease, cancer, and renal disease.
  • Prior PAP use within the previous 12 months.
  • Predominantly Central Apneas (≥ 50% central apneas) or Cheyne Stokes Respiration (CSR) (≥ 20% of Total Sleep Time (TST) with CSR)
  • Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake or the requirement for supplemental oxygen (at night or continuous) or mechanical ventilation.
  • Surgery involving the upper airway, nose, sinus, eye, teeth, or middle ear within the previous 90 days
  • PAP therapy is otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks

Treatment and study plan

structured adherence management program

Behavioral

Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy

Standard of Care

Behavioral

Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy

Primary outcomes

  1. Increase on CMS adherence requirements

    Time frame: at 90 days

    The requirements are greater than 4 hours use for 70% of nights

Secondary outcomes

  1. Nightly use of therapy

    Time frame: at 90 days

    Hours per night and % of nights with at least 4 hours of use

  2. Participant satisfaction

    Time frame: at 90 days

    Participants will complete at "Patients Satisfaction Survey" containing 5 questions about their satisfaction with CPAP treatment and the process of starting CPAP. There is a 5 point scale from very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very unsatisfied (5). Score can vary from 5 to 25. 30,

  3. Operational efficiencies and economic benefits to the health care facility

    Time frame: at 90 days

    Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Philips Respironics
  • US Department of Veterans Affairs

Registry information

Official study title

ThErapy Adherence Management in Veterans: A Randomized Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2017
Registry last updated
May 13, 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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