<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/NCT02195531</url>
  </required_header>
  <id_info>
    <org_study_id>PGI-BIG4-1331-MS</org_study_id>
    <nct_id>NCT02195531</nct_id>
  </id_info>
  <brief_title>CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence</brief_title>
  <official_title>BIG4 - CPAP Educational Materials and Usage Feedback to Promote CPAP Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Respironics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Respironics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis: in groups receiving tailored education and feedback in a style that&#xD;
      matches their psychological profile, will show a higher CPAP adherence rates than groups&#xD;
      receiving mismatched tailored education / feedback, and groups that receive no tailored&#xD;
      education and feedback (standard of care).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three group, randomized, controlled clinical trial assessing the extent to which tailoring a&#xD;
      CPAP intervention entailing education and feedback to the psychological profile of new CPAP&#xD;
      users can enhance the impact of the intervention in terms of adherence-related behavior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nightly Adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Average usage hours per night</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Average usage days per week.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant's Feedback on Educational Pamphlets - Expectations Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective.&#xD;
The average response for each questions was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Feedback on Educational Pamphlets - Importance Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree.&#xD;
The average of each question was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Feedback on Educational Pamphlets - Motiviation</measure>
    <time_frame>3 months</time_frame>
    <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much.&#xD;
The average of the questions were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Feedback on Educational Pamphlets - Leaflet Assessment</measure>
    <time_frame>2 months</time_frame>
    <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree.&#xD;
The average of the scores were calculated and analyzed monthly.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Adherence</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive education inconsistent with their profile.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not receive education or feedback.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education and feedback</intervention_name>
    <description>The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Education</other_name>
    <other_name>Motivational Enhancement technique</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females, ages 21-80 years&#xD;
&#xD;
          -  Prescribed to start CPAP treatment and diagnosed with mild to severe OSA.&#xD;
&#xD;
          -  Recently (within study period) diagnosed with Mild to Severe OSA defined as an&#xD;
             Apnea-Hypopnea Index of equal to or greater than 10 events per hour of sleep.&#xD;
&#xD;
          -  CPAP treatment naïve&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Presence of a comorbid condition that may potentially complicate CPAP adherence, such&#xD;
             as:&#xD;
&#xD;
               -  Unstable depressive disorder&#xD;
&#xD;
               -  Unstable anxiety disorder&#xD;
&#xD;
               -  Dementia&#xD;
&#xD;
               -  Unable to understand study information&#xD;
&#xD;
               -  Obesity Hypoventilation Syndrome&#xD;
&#xD;
               -  Central Sleep Apnea or Complex Sleep Apnea&#xD;
&#xD;
               -  Facial musculoskeletal disorder&#xD;
&#xD;
                    -  Unwillingness or inability to use CPAP therapy&#xD;
&#xD;
                    -  Unable to return for follow up appointment&#xD;
&#xD;
                    -  Use of supplemental oxygen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Bogan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SleepMed of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pulmonary Associates</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Center for Sleep Medicine</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroTrials, Inc.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SleepMed of Central Georgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SleepMed of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SleepMed of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>June 22, 2018</results_first_submitted>
  <results_first_submitted_qc>January 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 5, 2019</results_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adherence</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care</title>
          <description>Participants will not receive education or feedback.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Group</title>
          <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
        </group>
        <group group_id="P3">
          <title>Control Group</title>
          <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard of Care</title>
          <description>Participants will not receive education or feedback.</description>
        </group>
        <group group_id="B2">
          <title>Treatment</title>
          <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
        </group>
        <group group_id="B3">
          <title>Control Group</title>
          <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="63"/>
            <count group_id="B2" value="48"/>
            <count group_id="B3" value="55"/>
            <count group_id="B4" value="166"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.0" spread="12.5"/>
                    <measurement group_id="B2" value="50.5" spread="10.9"/>
                    <measurement group_id="B3" value="53.3" spread="12.8"/>
                    <measurement group_id="B4" value="50.5" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.5" spread="8.2"/>
                    <measurement group_id="B2" value="32.8" spread="5.6"/>
                    <measurement group_id="B3" value="33.6" spread="6.5"/>
                    <measurement group_id="B4" value="33.7" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Apnea-Hyopnea Index</title>
          <description>The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep</description>
          <units>events/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.7" spread="17.9"/>
                    <measurement group_id="B2" value="27.1" spread="16.1"/>
                    <measurement group_id="B3" value="28.2" spread="16.2"/>
                    <measurement group_id="B4" value="29.6" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Epworth Sleepiness Scale</title>
          <description>The Epworth Sleepiness Scale is an 8 item questionnaire that measures the general level of daytime sleepiness. Participants were asked what the chance is they would doze off or fall asleep during different routine daytime situations. The survey answers questions on a scale of 0 to 3- 0 being no chance and 3 being a high chance of dozing. The lowest score possible is a 0 and the highest score possible is a 24.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.1" spread="5.6"/>
                    <measurement group_id="B2" value="10.4" spread="5.3"/>
                    <measurement group_id="B3" value="11.2" spread="5.6"/>
                    <measurement group_id="B4" value="10.9" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Nightly Adherence</title>
        <description>Average usage hours per night</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O3">
            <title>Standard of Care</title>
            <description>Participants will not receive education or feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Nightly Adherence</title>
          <description>Average usage hours per night</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.83" spread="3.04"/>
                    <measurement group_id="O2" value="5.82" spread="3.08"/>
                    <measurement group_id="O3" value="4.82" spread="2.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.60" spread="3.09"/>
                    <measurement group_id="O2" value="4.96" spread="3.09"/>
                    <measurement group_id="O3" value="4.19" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.32" spread="3.10"/>
                    <measurement group_id="O2" value="4.94" spread="3.08"/>
                    <measurement group_id="O3" value="3.60" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.16" spread="3.18"/>
                    <measurement group_id="O2" value="4.63" spread="3.27"/>
                    <measurement group_id="O3" value="3.25" spread="3.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence</title>
        <description>Average usage days per week.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O3">
            <title>Standard of Care</title>
            <description>Participants will not receive education or feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence</title>
          <description>Average usage days per week.</description>
          <units>days per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.1"/>
                    <measurement group_id="O2" value="5.8" spread="1.7"/>
                    <measurement group_id="O3" value="4.9" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Feedback on Educational Pamphlets - Expectations Scale</title>
        <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective.&#xD;
The average response for each questions was analyzed.</description>
        <time_frame>3 months</time_frame>
        <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O3">
            <title>Standard of Care</title>
            <description>Participants will not receive education or feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Feedback on Educational Pamphlets - Expectations Scale</title>
          <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective.&#xD;
The average response for each questions was analyzed.</description>
          <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.42" spread="0.63"/>
                    <measurement group_id="O2" value="4.39" spread="0.80"/>
                    <measurement group_id="O3" value="4.33" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="0.85"/>
                    <measurement group_id="O2" value="4.01" spread="1.01"/>
                    <measurement group_id="O3" value="4.07" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.43" spread="0.70"/>
                    <measurement group_id="O2" value="4.26" spread="0.85"/>
                    <measurement group_id="O3" value="3.97" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="0.73"/>
                    <measurement group_id="O2" value="4.30" spread="0.79"/>
                    <measurement group_id="O3" value="3.99" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Feedback on Educational Pamphlets - Importance Scale</title>
        <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important.</description>
        <time_frame>3 months</time_frame>
        <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O3">
            <title>Standard of Care</title>
            <description>Participants will not receive education or feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Feedback on Educational Pamphlets - Importance Scale</title>
          <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important.</description>
          <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.69" spread="0.59"/>
                    <measurement group_id="O2" value="4.58" spread="0.71"/>
                    <measurement group_id="O3" value="4.65" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.53" spread="0.87"/>
                    <measurement group_id="O2" value="4.63" spread="0.72"/>
                    <measurement group_id="O3" value="4.62" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.65" spread="0.65"/>
                    <measurement group_id="O2" value="4.66" spread="0.71"/>
                    <measurement group_id="O3" value="4.36" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.86" spread="0.41"/>
                    <measurement group_id="O2" value="4.73" spread="0.60"/>
                    <measurement group_id="O3" value="4.31" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale</title>
        <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree.&#xD;
The average of each question was analyzed.</description>
        <time_frame>3 months</time_frame>
        <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O3">
            <title>Standard of Care</title>
            <description>Participants will not receive education or feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale</title>
          <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree.&#xD;
The average of each question was analyzed.</description>
          <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.49" spread="0.53"/>
                    <measurement group_id="O2" value="4.20" spread="0.84"/>
                    <measurement group_id="O3" value="4.29" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.26" spread="0.79"/>
                    <measurement group_id="O2" value="4.14" spread="0.86"/>
                    <measurement group_id="O3" value="4.07" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.29" spread="0.76"/>
                    <measurement group_id="O2" value="4.42" spread="0.81"/>
                    <measurement group_id="O3" value="4.14" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="0.98"/>
                    <measurement group_id="O2" value="4.30" spread="0.89"/>
                    <measurement group_id="O3" value="4.04" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Feedback on Educational Pamphlets - Motiviation</title>
        <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much.&#xD;
The average of the questions were analyzed.</description>
        <time_frame>3 months</time_frame>
        <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O3">
            <title>Standard of Care</title>
            <description>Participants will not receive education or feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Feedback on Educational Pamphlets - Motiviation</title>
          <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much.&#xD;
The average of the questions were analyzed.</description>
          <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.59" spread="0.56"/>
                    <measurement group_id="O2" value="9.32" spread="1.14"/>
                    <measurement group_id="O3" value="9.21" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.10" spread="1.35"/>
                    <measurement group_id="O2" value="8.82" spread="1.75"/>
                    <measurement group_id="O3" value="8.85" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.38" spread="0.97"/>
                    <measurement group_id="O2" value="9.25" spread="1.59"/>
                    <measurement group_id="O3" value="8.97" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.11" spread="1.23"/>
                    <measurement group_id="O2" value="8.98" spread="1.81"/>
                    <measurement group_id="O3" value="8.57" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Feedback on Educational Pamphlets - Leaflet Assessment</title>
        <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree.&#xD;
The average of the scores were calculated and analyzed monthly.</description>
        <time_frame>2 months</time_frame>
        <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Feedback on Educational Pamphlets - Leaflet Assessment</title>
          <description>Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.&#xD;
Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree.&#xD;
The average of the scores were calculated and analyzed monthly.</description>
          <population>As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.12" spread="0.46"/>
                    <measurement group_id="O2" value="4.04" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" spread="0.58"/>
                    <measurement group_id="O2" value="3.95" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.07" spread="0.74"/>
                    <measurement group_id="O2" value="3.99" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All non-serious and serious adverse events were collected over the 3 month period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>Participants will receive education and feedback tailored to the psychological profile of the receiving participant.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Participants will receive education inconsistent with their profile.&#xD;
Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns.</description>
        </group>
        <group group_id="E3">
          <title>Standard of Care</title>
          <description>Participants will not receive education or feedback.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Scientist</name_or_title>
      <organization>Philips Research</organization>
      <phone>+31628041122</phone>
      <email>Joyca.lacroix@philips.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02195531
org study id: PGI-BIG4-1331-MS
nct id: NCT02195531
lead sponsor: 
has dmc: No
The study hypothesis: in groups receiving tailored education and feedback in a style that
      matches their psychological profile, will show a higher CPAP adherence rates than groups
      receiving mismatched tailored education / feedback, and groups that receive no tailored
      education and feedback (standard of care).
Three group, randomized, controlled clinical trial assessing the extent to which tailoring a
      CPAP intervention entailing education and feedback to the psychological profile of new CPAP
      users can enhance the impact of the intervention in terms of adherence-related behavior.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Nightly Adherence
time frame: 3 months
description: Average usage hours per night
measure: Adherence
time frame: 3 months
description: Average usage days per week.
measure: Participant's Feedback on Educational Pamphlets - Expectations Scale
time frame: 3 months
description: Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective.
The average response for each questions was analyzed.
measure: Participant's Feedback on Educational Pamphlets - Importance Scale
time frame: 3 months
description: Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important.
measure: Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
time frame: 3 months
description: Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree.
The average of each question was analyzed.
measure: Participant's Feedback on Educational Pamphlets - Motiviation
time frame: 3 months
description: Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much.
The average of the questions were analyzed.
measure: Participant's Feedback on Educational Pamphlets - Leaflet Assessment
time frame: 2 months
description: Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree.
The average of the scores were calculated and analyzed monthly.
arm group label: Treatment
arm group type: Active Comparator
description: Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
arm group label: Control Group
arm group type: Active Comparator
description: Participants will receive education inconsistent with their profile.
arm group label: Standard of care
arm group type: No Intervention
description: Participants will not receive education or feedback.
intervention type: Behavioral
intervention name: Education and feedback
description: The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.
arm group label: Control Group
arm group label: Treatment
other name: Education
other name: Motivational Enhancement technique
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Richard Bogan, MD
role: Principal Investigator
affiliation: SleepMed of South Carolina
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 