- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03039660
Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students
January 12, 2023 updated by: Sara Grace Connolly, Stanford University
Evidence-Based Online Curriculum to Improve Sleep in Medical Students: A Multisite Trial to Assess Efficacy and Feasibility of RefreshMD
This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Missouri
-
Saint Louis, Missouri, United States, 63130
- Washington University in St Louis
-
-
New Jersey
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Piscataway, New Jersey, United States, 08854
- Rutgers Robert Wood Johnson
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Full-time medical student at a participating medical school
- Will remain enrolled as full-time medical student throughout duration of study
Exclusion Criteria:
- Not a full-time medical student at a participating medical school
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RefreshMD
An online course for sleep improvement in medical students
|
Online Sleep Improvement Course
|
|
Placebo Comparator: Bond Between Us
An online course covering communication skills and the physician-patient relationship
|
Online Educational Course
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment numbers per course
Time Frame: 2 weeks
|
# of participants who enroll / # of participants invited to enroll
|
2 weeks
|
|
Views per video
Time Frame: Throughout the course (6 weeks)
|
Throughout the course (6 weeks)
|
|
|
Number of actively engaged students per course
Time Frame: Throughout the course (6 weeks)
|
Throughout the course (6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment
Time Frame: Through study completion (4 months)
|
Through study completion (4 months)
|
|
PROMIS Sleep Disturbance
Time Frame: Through study completion (4 months)
|
Through study completion (4 months)
|
|
PROMIS Depression
Time Frame: Through study completion (4 months)
|
Through study completion (4 months)
|
|
Stanford Medical Student Burnout Questionnaire
Time Frame: Through study completion (4 months)
|
Through study completion (4 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara G Cadman, MD, Stanford University graduate, Penn Medicine Fellow
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2017
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
January 27, 2017
First Submitted That Met QC Criteria
January 30, 2017
First Posted (Estimate)
February 1, 2017
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- RefreshMD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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