ThErapy Adherence Management in Veterans

Obstructive Sleep Apnea of Adult Clinical Trial

Official title: ThErapy Adherence Management in Veterans: A Randomized Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea, Obstructive

• NCT number: NCT03243487
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Completion date: May 9, 2019