<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/NCT03039660</url>
  </required_header>
  <id_info>
    <org_study_id>RefreshMD</org_study_id>
    <nct_id>NCT03039660</nct_id>
  </id_info>
  <brief_title>Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students</brief_title>
  <official_title>Evidence-Based Online Curriculum to Improve Sleep in Medical Students: A Multisite Trial to Assess Efficacy and Feasibility of RefreshMD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <brief_summary>
    <textblock>
      This study aims to investigate the feasibility and efficacy of online student wellness&#xD;
      courses for improving medical student mental health and well-being.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enrollment numbers per course</measure>
    <time_frame>2 weeks</time_frame>
    <description># of participants who enroll / # of participants invited to enroll</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Views per video</measure>
    <time_frame>Throughout the course (6 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of actively engaged students per course</measure>
    <time_frame>Throughout the course (6 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment</measure>
    <time_frame>Through study completion (4 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Sleep Disturbance</measure>
    <time_frame>Through study completion (4 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Depression</measure>
    <time_frame>Through study completion (4 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stanford Medical Student Burnout Questionnaire</measure>
    <time_frame>Through study completion (4 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Student Wellness</condition>
  <arm_group>
    <arm_group_label>RefreshMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An online course for sleep improvement in medical students</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bond Between Us</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>An online course covering communication skills and the physician-patient relationship</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RefreshMD</intervention_name>
    <description>Online Sleep Improvement Course</description>
    <arm_group_label>RefreshMD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bond Between Us</intervention_name>
    <description>Online Educational Course</description>
    <arm_group_label>Bond Between Us</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full-time medical student at a participating medical school&#xD;
&#xD;
          -  Will remain enrolled as full-time medical student throughout duration of study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a full-time medical student at a participating medical school&#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>Sara G Cadman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University graduate, Penn Medicine Fellow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Robert Wood Johnson</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Sara Grace Connolly</investigator_full_name>
    <investigator_title>Medical Student</investigator_title>
  </responsible_party>
  <!-- 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/NCT03039660
org study id: RefreshMD
nct id: NCT03039660
lead sponsor: 
This study aims to investigate the feasibility and efficacy of online student wellness
      courses for improving medical student mental health and well-being.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Enrollment numbers per course
time frame: 2 weeks
description: # of participants who enroll / # of participants invited to enroll
measure: Views per video
time frame: Throughout the course (6 weeks)
measure: Number of actively engaged students per course
time frame: Throughout the course (6 weeks)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment
time frame: Through study completion (4 months)
measure: PROMIS Sleep Disturbance
time frame: Through study completion (4 months)
measure: PROMIS Depression
time frame: Through study completion (4 months)
measure: Stanford Medical Student Burnout Questionnaire
time frame: Through study completion (4 months)
arm group label: RefreshMD
arm group type: Experimental
description: An online course for sleep improvement in medical students
arm group label: Bond Between Us
arm group type: Placebo Comparator
description: An online course covering communication skills and the physician-patient relationship
intervention type: Behavioral
intervention name: RefreshMD
description: Online Sleep Improvement Course
arm group label: RefreshMD
intervention type: Behavioral
intervention name: Bond Between Us
description: Online Educational Course
arm group label: Bond Between Us
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sara G Cadman, MD
role: Principal Investigator
affiliation: Stanford University graduate, Penn Medicine Fellow
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Sara Grace Connolly
investigator title: Medical Student