ThErapy Adherence Management in Veterans



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 85
Updated:7/1/2018
Start Date:August 8, 2017
End Date:August 2019
Contact:Richard b Berry, MD
Email:richard.berry@medicine.ufl.edu
Phone:3522621575

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ThErapy Adherence Management in Veterans: A Randomized Trial

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.

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)

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
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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