ThErapy Adherence Management in Veterans
NCT03243487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2019-05-13
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.
Conditions
- Obstructive Sleep Apnea of Adult
Interventions
- BEHAVIORAL
-
structured adherence management program
Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy
- BEHAVIORAL
-
Standard of care
Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy
Sponsors & Collaborators
-
Philips Respironics
collaborator INDUSTRY -
US Department of Veterans Affairs
collaborator FED -
University of Florida
lead OTHER
Principal Investigators
-
Richard B Berry, MD · Malcom Randall VAMC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-08
- Primary Completion
- 2019-05-09
- Completion
- 2019-05-09
Countries
- United States
Study Locations
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