ThErapy Adherence Management in Veterans

University of Florida

Status: Completed

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Behavioral: structured adherence management program; Behavioral: Standard of care

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT03243487

ST-17043-VAPAM-JP (Other Identifier)

IRB201701153

Details and patient eligibility

About

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.

Full 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)

Enrollment: 250 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

PAMS service

Experimental group

Description:

Study participants will be randomly assigned to have their Continuous positive airway pressure therapy (CPAP) or Bilevel Positive Airway Pressure (BiPAP) therapy followed by a structured patient adherence management service (PAMS). Interventions: Call to patient by sleep coach on days 3,7,14,32,45, 60, and 75 after participants begin PAP treatment. At each time frame sleep coach reviews CPAP adherence data on EncoreAnywhere (EA) a cloud based program collecting adherence data via wireless modem on CPAP units. Calls will not be made at days 7 and 14 if adherence is good. If problems are identified and cannot be handled over the telephone the problems will be escalated to VA MD or CPAP respiratory therapy (RT) providers for direct intervention. All patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment.

Treatment:

Behavioral: structured adherence management program

Standard Care (SCP)

Active Comparator group

Description:

Study participants will be randomly assigned to have their CPAP or BiPAP therapy followed by the current Sleep Center standard care process. This includes a telephone number that patients can call or problems and review of adherence data on EncoreAnywhere (EA) at 4 to 6 weeks after starting treatment. Patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment.

Treatment:

Behavioral: Standard of care