ThErapy Adherence Management in Veterans
- Conditions
- Obstructive Sleep Apnea of Adult
- Registration Number
- NCT03243487
- Lead Sponsor
- University of Florida
- Brief Summary
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.
- Detailed Description
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:
1. Results in higher nightly use of therapy (hours per night and % of nights with at least 4 hours of use) at 90 days
2. Results in participant satisfaction that is superior to current standard care
3. 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)
4. Results in indirect benefits to participants (fewer clinic visits, less travel or in-clinic/ office visit waiting time)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Increase on CMS adherence requirements at 90 days The requirements are greater than 4 hours use for 70% of nights
- Secondary Outcome Measures
Name Time Method Operational efficiencies and economic benefits to the health care facility at 90 days Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time
Participant satisfaction 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,
Nightly use of therapy at 90 days Hours per night and % of nights with at least 4 hours of use
Trial Locations
- Locations (2)
Malcom Randall VA Medical Center
🇺🇸Gainesville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Malcom Randall VA Medical Center🇺🇸Gainesville, Florida, United States