<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/NCT03835572</url>
  </required_header>
  <id_info>
    <org_study_id>20180932</org_study_id>
    <nct_id>NCT03835572</nct_id>
  </id_info>
  <brief_title>CircaHealth Development and Evaluation</brief_title>
  <official_title>Evaluation of Circadian Health Educational Tool</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quantum Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</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>
      This study evaluates the feasibility, acceptability, and efficacy of an online education&#xD;
      course about circadian rhythms and health. Half of participants will be enrolled into the&#xD;
      online course and the other half will receive materials on sleep hygiene as a control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot randomized controlled study that aims to develop CircaHealth: an online&#xD;
      course on practices, known as circadian hygiene, that promote circadian rhythm alignment and&#xD;
      minimize circadian rhythm misalignment. The project also will determine the feasibility,&#xD;
      acceptability, and preliminary effects of CircaHealth in improving circadian rhythm related&#xD;
      measures in University of Miami Miller School of Medicine medical students.&#xD;
&#xD;
      The educational videos will be incorporated into a six-module online course which contains&#xD;
      additional educational and behavior modification tools. Medical students (n = 40) will be&#xD;
      recruited via email and randomized to receive CircaHealth or materials from the National&#xD;
      Sleep Foundation and/or the American Academy of Sleep Medicine. Sleep, mood, and circadian&#xD;
      hygiene knowledge, behaviors, and attitudes will be assessed at baseline and four weeks post&#xD;
      intervention. Feasibility will be determined by CircaHealth module completion rates, and&#xD;
      acceptability will be assessed via a self-report survey. Changes in sleep quality measures&#xD;
      between groups will determine the preliminary efficacy of CircaHealth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2019</start_date>
  <completion_date type="Actual">May 8, 2019</completion_date>
  <primary_completion_date type="Actual">May 8, 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>Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Participants will be assigned a study ID such that the investigators cannot determine the identify of the participants or which arm of the study each participant is in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Participant completion rate of CircaHealth</measure>
    <time_frame>Six weeks</time_frame>
    <description>Determine how many participants completed all modules within CircaHealth. Participants status in the course will be assessed via survey weekly such that their completion of each module can be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant qualitative feedback on CircaHealth</measure>
    <time_frame>Six weeks</time_frame>
    <description>Participants will be surveyed every week on what aspects of CircaHealth were helpful and what aspects of CircaHealth can be improved. This qualitative data will be analyzed to determine which aspects of CircaHealth positively and negatively impacted the educational value of the course.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Epworth Sleepiness Scale scores four weeks after the completion of CircaHealth</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Epworth Sleepiness Scale scores improved four weeks after completion of the educational intervention in comparison to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index scores four weeks after the completion of CircaHealth</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Pittsburgh Sleep Quality Index scores improved four weeks after completion of the educational intervention in comparison to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Munich Chronotype scores four weeks after the completion of CircaHealth</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Munich Chronotype scores improved four weeks after completion of the educational intervention in comparison to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Circadian Health Scale scores four weeks after the completion of CircaHealth</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Circadian Health Scale scores improved four weeks after completion of the educational intervention in comparison to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maslach General Survey for Students scores four weeks after the completion of CircaHealth</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Maslach General Survey for Students scores improved four weeks after completion of the educational intervention in comparison to the control group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Association between Epworth Sleepiness Scale scores and Circadian Health Scale scores</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Epworth Sleepiness Scale scores are associated with Circadian Health Scale scores</description>
  </other_outcome>
  <other_outcome>
    <measure>Association between Pittsburgh Sleep Quality Index scores and Circadian Health Scale scores</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Pittsburgh Sleep Quality Index scores are associated with Circadian Health Scale scores</description>
  </other_outcome>
  <other_outcome>
    <measure>Association between Munich Chronotype scores and Circadian Health Scale scores</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Munich Chronotype scores are associated with Circadian Health Scale scores</description>
  </other_outcome>
  <other_outcome>
    <measure>Association between Maslach General Survey for Students scores and Circadian Health Scale scores</measure>
    <time_frame>Ten weeks</time_frame>
    <description>To determine if Maslach General Survey for Students scores are associated with Circadian Health Scale scores</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Health Behavior</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <condition>Circadian Rhythm</condition>
  <arm_group>
    <arm_group_label>CircaHealth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The CircaHealth group will receive access to an online educational module on circadian rhythms and health as their intervention. Every week for six weeks, these participants will receive a new module that contains videos, quizzes, behavioral modification checklists, and journal prompts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep hygiene materials</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive publicly available materials about sleep hygiene from the National Sleep Foundation and/or the American Academy of Sleep Medicine every week for six weeks as their intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CircaHealth: a course on circadian rhythms and health</intervention_name>
    <description>Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.</description>
    <arm_group_label>CircaHealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep hygiene materials</intervention_name>
    <description>Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene</description>
    <arm_group_label>Sleep hygiene materials</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical students, 1st through 4th year, at the University of Miami Miller School of&#xD;
             Medicine willing to participate in surveys and the CircaHealth course.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tulay Koru-Sengal, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Dylan Petkus</investigator_full_name>
    <investigator_title>Student Doctor</investigator_title>
  </responsible_party>
  <keyword>Circadian Rhythm</keyword>
  <keyword>Education</keyword>
  <keyword>Student burnout</keyword>
  <keyword>Sleep Hygiene</keyword>
  <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/NCT03835572
org study id: 20180932
nct id: NCT03835572
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the feasibility, acceptability, and efficacy of an online education
      course about circadian rhythms and health. Half of participants will be enrolled into the
      online course and the other half will receive materials on sleep hygiene as a control.
This is a pilot randomized controlled study that aims to develop CircaHealth: an online
      course on practices, known as circadian hygiene, that promote circadian rhythm alignment and
      minimize circadian rhythm misalignment. The project also will determine the feasibility,
      acceptability, and preliminary effects of CircaHealth in improving circadian rhythm related
      measures in University of Miami Miller School of Medicine medical students.

      The educational videos will be incorporated into a six-module online course which contains
      additional educational and behavior modification tools. Medical students (n = 40) will be
      recruited via email and randomized to receive CircaHealth or materials from the National
      Sleep Foundation and/or the American Academy of Sleep Medicine. Sleep, mood, and circadian
      hygiene knowledge, behaviors, and attitudes will be assessed at baseline and four weeks post
      intervention. Feasibility will be determined by CircaHealth module completion rates, and
      acceptability will be assessed via a self-report survey. Changes in sleep quality measures
      between groups will determine the preliminary efficacy of CircaHealth.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.
primary purpose: Treatment
masking: Single (Investigator)
masking description: Participants will be assigned a study ID such that the investigators cannot determine the identify of the participants or which arm of the study each participant is in.
measure: Participant completion rate of CircaHealth
time frame: Six weeks
description: Determine how many participants completed all modules within CircaHealth. Participants status in the course will be assessed via survey weekly such that their completion of each module can be determined.
measure: Participant qualitative feedback on CircaHealth
time frame: Six weeks
description: Participants will be surveyed every week on what aspects of CircaHealth were helpful and what aspects of CircaHealth can be improved. This qualitative data will be analyzed to determine which aspects of CircaHealth positively and negatively impacted the educational value of the course.
measure: Change in Epworth Sleepiness Scale scores four weeks after the completion of CircaHealth
time frame: Ten weeks
description: To determine if Epworth Sleepiness Scale scores improved four weeks after completion of the educational intervention in comparison to the control group.
measure: Change in Pittsburgh Sleep Quality Index scores four weeks after the completion of CircaHealth
time frame: Ten weeks
description: To determine if Pittsburgh Sleep Quality Index scores improved four weeks after completion of the educational intervention in comparison to the control group.
measure: Change in Munich Chronotype scores four weeks after the completion of CircaHealth
time frame: Ten weeks
description: To determine if Munich Chronotype scores improved four weeks after completion of the educational intervention in comparison to the control group.
measure: Change in Circadian Health Scale scores four weeks after the completion of CircaHealth
time frame: Ten weeks
description: To determine if Circadian Health Scale scores improved four weeks after completion of the educational intervention in comparison to the control group.
measure: Change in Maslach General Survey for Students scores four weeks after the completion of CircaHealth
time frame: Ten weeks
description: To determine if Maslach General Survey for Students scores improved four weeks after completion of the educational intervention in comparison to the control group.
measure: Association between Epworth Sleepiness Scale scores and Circadian Health Scale scores
time frame: Ten weeks
description: To determine if Epworth Sleepiness Scale scores are associated with Circadian Health Scale scores
measure: Association between Pittsburgh Sleep Quality Index scores and Circadian Health Scale scores
time frame: Ten weeks
description: To determine if Pittsburgh Sleep Quality Index scores are associated with Circadian Health Scale scores
measure: Association between Munich Chronotype scores and Circadian Health Scale scores
time frame: Ten weeks
description: To determine if Munich Chronotype scores are associated with Circadian Health Scale scores
measure: Association between Maslach General Survey for Students scores and Circadian Health Scale scores
time frame: Ten weeks
description: To determine if Maslach General Survey for Students scores are associated with Circadian Health Scale scores
arm group label: CircaHealth
arm group type: Experimental
description: The CircaHealth group will receive access to an online educational module on circadian rhythms and health as their intervention. Every week for six weeks, these participants will receive a new module that contains videos, quizzes, behavioral modification checklists, and journal prompts.
arm group label: Sleep hygiene materials
arm group type: Active Comparator
description: The control group will receive publicly available materials about sleep hygiene from the National Sleep Foundation and/or the American Academy of Sleep Medicine every week for six weeks as their intervention.
intervention type: Other
intervention name: CircaHealth: a course on circadian rhythms and health
description: Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.
arm group label: CircaHealth
intervention type: Other
intervention name: Sleep hygiene materials
description: Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene
arm group label: Sleep hygiene materials
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tulay Koru-Sengal, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Dylan Petkus
investigator title: Student Doctor
sharing ipd: No