<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243487</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701153</org_study_id>
    <secondary_id>ST-17043-VAPAM-JP</secondary_id>
    <nct_id>NCT03243487</nct_id>
  </id_info>
  <brief_title>ThErapy Adherence Management in Veterans</brief_title>
  <official_title>ThErapy Adherence Management in Veterans: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Respironics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective, randomized, controlled trial studying adherence to positive&#xD;
      airway pressure therapy in a population referred to the VA system for the treatment of sleep&#xD;
      disordered breathing. The primary aim of the study is to determine if, compared to standard&#xD;
      care provided at a VA Sleep Center, the deployment of a structured adherence management&#xD;
      program and a web-based information program designed for participants beginning positive&#xD;
      airway pressure therapy results in a greater portion of participants meeting Centers for&#xD;
      Medicare &amp; Medicaid Services (CMS) adherence requirements (use &gt; 4 hours for &gt;= 70% of days)&#xD;
      at 90 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of the study is to determine if, compared to standard care provided at a VA&#xD;
      Sleep Center, the deployment of a structured adherence management program and a web-based&#xD;
      information program designed for participants beginning positive airway pressure therapy&#xD;
      results in a greater portion of participants meeting CMS adherence requirements (use &gt; 4hrs&#xD;
      on &gt;=70% of nights) at 90 days.&#xD;
&#xD;
      Secondary aims:&#xD;
&#xD;
        1. Results in higher nightly use of therapy (hours per night and % of nights with at least&#xD;
           4 hours of use) at 90 days&#xD;
&#xD;
        2. Results in participant satisfaction that is superior to current standard care&#xD;
&#xD;
        3. Offers operational efficiencies or economic benefits to the health care facility&#xD;
           (reduced staff time (sleep clinic and physician), equipment consumption, unplanned&#xD;
           participant contacts or visits, and reduced overtime)&#xD;
&#xD;
        4. Results in indirect benefits to participants (fewer clinic visits, less travel or&#xD;
           in-clinic/ office visit waiting time)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">May 9, 2019</completion_date>
  <primary_completion_date type="Actual">May 9, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Increase on CMS adherence requirements</measure>
    <time_frame>at 90 days</time_frame>
    <description>The requirements are greater than 4 hours use for 70% of nights</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nightly use of therapy</measure>
    <time_frame>at 90 days</time_frame>
    <description>Hours per night and % of nights with at least 4 hours of use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction</measure>
    <time_frame>at 90 days</time_frame>
    <description>Participants will complete at &quot;Patients Satisfaction Survey&quot; 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,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operational efficiencies and economic benefits to the health care facility</measure>
    <time_frame>at 90 days</time_frame>
    <description>Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Obstructive Sleep Apnea of Adult</condition>
  <arm_group>
    <arm_group_label>PAMS service</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care (SCP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>structured adherence management program</intervention_name>
    <description>Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy</description>
    <arm_group_label>PAMS service</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy</description>
    <arm_group_label>Standard Care (SCP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 21 to 85&#xD;
&#xD;
          -  Diagnostic Apnoea-Hypopnoea Index (AHI) ≥ 15 determined by in lab polysomnography&#xD;
             (PSG) or home sleep testing (HST) or by a sleep therapy device&#xD;
&#xD;
          -  Eligible for treatment with Automatically adjusted CPAP or Automatically adjusted&#xD;
             BiPAP&#xD;
&#xD;
          -  Currently has a Smart Phone or home access (computer with internet access) to the&#xD;
             internet based version of the software application&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another interventional research concerned with sleep disorders within&#xD;
             the last 30 days&#xD;
&#xD;
          -  Major uncontrolled medical condition that would interfere with the demands of the&#xD;
             study, adherence to PAP, or the ability to commit to follow-up assessment including&#xD;
             conditions such as poorly managed or controlled or advanced stages of pulmonary&#xD;
             disease, cardiac disease, neurological disease, neuromuscular disease, cancer, and&#xD;
             renal disease.&#xD;
&#xD;
          -  Prior PAP use within the previous 12 months.&#xD;
&#xD;
          -  Predominantly Central Apneas (≥ 50% central apneas) or Cheyne Stokes Respiration (CSR)&#xD;
             (≥ 20% of Total Sleep Time (TST) with CSR)&#xD;
&#xD;
          -  Chronic respiratory failure or insufficiency with suspected or known neuromuscular&#xD;
             disease, moderate chronic obstructive pulmonary disease (COPD), or any condition with&#xD;
             an elevation of arterial carbon dioxide levels while awake or the requirement for&#xD;
             supplemental oxygen (at night or continuous) or mechanical ventilation.&#xD;
&#xD;
          -  Surgery involving the upper airway, nose, sinus, eye, teeth, or middle ear within the&#xD;
             previous 90 days&#xD;
&#xD;
          -  PAP therapy is otherwise medically complicated or contraindicated such as those with a&#xD;
             difficult to size or adjust interface (mask) resulting in facial pain, skin irritation&#xD;
             or trauma, or excessive air leaks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard B Berry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malcom Randall VAMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malcom Randall VA Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>19136368</PMID>
  </reference>
  <reference>
    <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>
    <PMID>20880872</PMID>
  </reference>
  <reference>
    <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>
    <PMID>22467985</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24179298</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>23772186</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243487
org study id: IRB201701153
secondary id: ST-17043-VAPAM-JP
nct id: NCT03243487
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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)
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Single (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.
measure: Increase on CMS adherence requirements
time frame: at 90 days
description: The requirements are greater than 4 hours use for 70% of nights
measure: Nightly use of therapy
time frame: at 90 days
description: Hours per night and % of nights with at least 4 hours of use
measure: Participant satisfaction
time frame: at 90 days
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,
measure: Operational efficiencies and economic benefits to the health care facility
time frame: at 90 days
description: Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time
arm group label: PAMS service
arm group type: Experimental
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 group label: Standard Care (SCP)
arm group type: Active Comparator
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: structured adherence management program
description: Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy
arm group label: PAMS service
intervention type: Behavioral
intervention name: Standard of care
description: Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy
arm group label: Standard Care (SCP)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Richard B Berry, MD
role: Principal Investigator
affiliation: Malcom Randall VAMC
facility: 
facility: 
country: United States
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.
PMID: 19136368
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.
PMID: 20880872
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.
PMID: 22467985
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.
PMID: 24179298
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.
PMID: 23772186
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: No