ThErapy Adherence Management in Veterans

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

ThErapy Adherence Management in Veterans: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243487
• Other study ID #: IRB201701153
• Secondary ID: ST-17043-VAPAM-J
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: May 9, 2019

Study information

• Verified date: May 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea, Obstructive

Intervention

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
• Standard of care
Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Philips Respironics, US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase on CMS adherence requirements	The requirements are greater than 4 hours use for 70% of nights	at 90 days
Secondary	Nightly use of therapy	Hours per night and % of nights with at least 4 hours of use	at 90 days
Secondary	Participant satisfaction	Participants will complete at "Patients Satisfaction Survey" containing 5 questions about their satisfaction with CPAP treatment and the process of starting CPAP. There is a 5 point scale from very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very unsatisfied (5). Score can vary from 5 to 25. 30,	at 90 days
Secondary	Operational efficiencies and economic benefits to the health care facility	Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time	at 90 days