NCT03243487

ThErapy Adherence Management in Veterans

ThErapy Adherence Management in Veterans: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-08
• Primary completion: 2019-05-09
• Completion: 2019-05-09
• First posted: 2017-08-09
• Last updated: 2019-05-13

Locations

2 sites across 1 country: United States