Clinical trial NCT03243487: ThErapy Adherence Management in Veterans
Official title: ThErapy Adherence Management in Veterans: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Philips Respironics
name: US Department of Veterans Affairs
First posted: 2017-08-09
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After undergoing screening and enrollment, participants will be assigned to either standard care follow-up or to the patient adherence monitoring service (PAMS).
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Increase on CMS adherence requirements
timeFrame: at 90 days
Secondary outcomes:
measure: Nightly use of therapy
timeFrame: at 90 days
measure: Participant satisfaction
timeFrame: at 90 days
measure: Operational efficiencies and economic benefits to the health care facility
timeFrame: at 90 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Malcom Randall VAMC
name: Richard B Berry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antic NA, Buchan C, Esterman A, Hensley M, Naughton MT, Rowland S, Williamson B, Windler S, Eckermann S, McEvoy RD. A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Mar 15;179(6):501-8. doi: 10.1164/rccm.200810-1558OC. Epub 2009 Jan 8.
citation: Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
citation: Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.
citation: Aloia MS, Arnedt JT, Strand M, Millman RP, Borrelli B. Motivational enhancement to improve adherence to positive airway pressure in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2013 Nov 1;36(11):1655-62. doi: 10.5665/sleep.3120.
citation: Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2013 Jun 15;9(6):543-50. doi: 10.5664/jcsm.2744.
citation: Berry RB, Beck E, Jasko JG. Effect of cloud-based sleep coaches on positive airway pressure adherence. J Clin Sleep Med. 2020 Apr 15;16(4):553-562. doi: 10.5664/jcsm.8276.