Back to resultsThErapy Adherence Management in Veterans
Primary Purpose
Obstructive Sleep Apnea of Adult
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
structured adherence management program
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea of Adult
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
Sites / Locations
- Malcom Randall VA Medical Center
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PAMS service
Standard Care (SCP)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Increase on CMS adherence requirements
The requirements are greater than 4 hours use for 70% of nights
Secondary Outcome Measures
Nightly use of therapy
Hours per night and % of nights with at least 4 hours of use
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,
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
Full Information
NCT ID
NCT03243487
First Posted
August 4, 2017
Last Updated
May 10, 2019
Sponsor
University of Florida
Collaborators
Philips Respironics, US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT03243487
Brief Title
ThErapy Adherence Management in Veterans
Official Title
ThErapy Adherence Management in Veterans: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
May 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Philips Respironics, US Department of Veterans Affairs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Results in higher nightly use of therapy (hours per night and % of nights with at least 4 hours of use) at 90 days
Results in participant satisfaction that is superior to current standard care
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)
Results in indirect benefits to participants (fewer clinic visits, less travel or in-clinic/ office visit waiting time)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAMS service
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care (SCP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
structured adherence management program
Intervention Description
Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy
Primary Outcome Measure Information:
Title
Increase on CMS adherence requirements
Description
The requirements are greater than 4 hours use for 70% of nights
Time Frame
at 90 days
Secondary Outcome Measure Information:
Title
Nightly use of therapy
Description
Hours per night and % of nights with at least 4 hours of use
Time Frame
at 90 days
Title
Participant satisfaction
Description
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,
Time Frame
at 90 days
Title
Operational efficiencies and economic benefits to the health care facility
Description
Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time
Time Frame
at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Berry, MD
Organizational Affiliation
Malcom Randall VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19136368
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.
Results Reference
background
PubMed Identifier
20880872
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.
Results Reference
background
PubMed Identifier
22467985
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.
Results Reference
background
PubMed Identifier
24179298
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.
Results Reference
background
PubMed Identifier
23772186
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.
Results Reference
result
PubMed Identifier
32022679
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.
Results Reference
derived
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ThErapy Adherence Management in Veterans
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