ThErapy Adherence Management in Veterans

NCT03243487 | Completed

• 2 other identifiers: IRB201701153ST-17043-VAPAM-JP
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Increase on CMS adherence requirements

  The requirements are greater than 4 hours use for 70% of nights

  at 90 days

Secondary Outcomes (3)

• Nightly use of therapy

  at 90 days

• Participant satisfaction

  at 90 days

• Operational efficiencies and economic benefits to the health care facility

  at 90 days

Study Arms (2)

PAMS service

EXPERIMENTAL

Study participants will be randomly assigned to have their Continuous positive airway pressure therapy (CPAP) or Bilevel Positive Airway Pressure (BiPAP) therapy followed by a structured patient adherence management service (PAMS). Interventions: Call to patient by sleep coach on days 3,7,14,32,45, 60, and 75 after participants begin PAP treatment. At each time frame sleep coach reviews CPAP adherence data on EncoreAnywhere (EA) a cloud based program collecting adherence data via wireless modem on CPAP units. Calls will not be made at days 7 and 14 if adherence is good. If problems are identified and cannot be handled over the telephone the problems will be escalated to VA MD or CPAP respiratory therapy (RT) providers for direct intervention. All patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment.

Behavioral: structured adherence management program

Standard Care (SCP)

ACTIVE COMPARATOR

Study participants will be randomly assigned to have their CPAP or BiPAP therapy followed by the current Sleep Center standard care process. This includes a telephone number that patients can call or problems and review of adherence data on EncoreAnywhere (EA) at 4 to 6 weeks after starting treatment. Patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment.

Behavioral: Standard of care

Interventions

structured adherence management program BEHAVIORAL

Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy

PAMS service

Standard of care BEHAVIORAL

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

Standard Care (SCP)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Philips Respironics: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (2)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (6)

• 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.

  PMID: 19136368 BACKGROUND

• 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.

  PMID: 20880872 BACKGROUND

• 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.

  PMID: 22467985 BACKGROUND

• 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.

  PMID: 24179298 BACKGROUND

• 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.

  PMID: 23772186 RESULT

• 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.

  PMID: 32022679 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Richard B Berry, MD

  Malcom Randall VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study participants and study staff cannot be blinded to the treatment arm to which they are randomized. Data analysis will be blinded and conducted without revealing the treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After undergoing screening and enrollment, participants will be assigned to either standard care follow-up or to the patient adherence monitoring service (PAMS).

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 9, 2017
• Study Start: August 8, 2017
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)