Student WellnessNCT03039660
Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students
A study testing RefreshMD and Bond Between Us in people with Student Wellness, run by Stanford University at 3 sites in United States.
Trial summary
This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Student Wellness
- What is being tested?
- RefreshMD and Bond Between Us
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jan 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Full-time medical student at a participating medical school
- Will remain enrolled as full-time medical student throughout duration of study
Who cannot join
- Not a full-time medical student at a participating medical school
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rutgers Robert Wood Johnson
Piscataway, New Jersey, 08854
Washington University in St Louis
St Louis, Missouri, 63130
Stanford University
Stanford, California, 94305
About this study
Official title: 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.
- Conditions
- Student Wellness
- Being tested
- RefreshMD, Bond Between Us
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RefreshMDBehavioural
Online Sleep Improvement Course
Bond Between UsBehavioural
Online Educational Course
| Study group | Role | What they receive |
|---|---|---|
| RefreshMD | Experimental | An online course for sleep improvement in medical students Receives: Behavioral: RefreshMD |
| Bond Between Us | Placebo comparator | An online course covering communication skills and the physician-patient relationship Receives: Behavioral: Bond Between Us |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment numbers per course
# of participants who enroll / # of participants invited to enroll
Measured: 2 weeks
Views per video
Measured: Throughout the course (6 weeks)
Number of actively engaged students per course
Measured: Throughout the course (6 weeks)
Secondary outcomes (4)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment
Measured: Through study completion (4 months)
PROMIS Sleep Disturbance
Measured: Through study completion (4 months)
PROMIS Depression
Measured: Through study completion (4 months)
Stanford Medical Student Burnout Questionnaire
Measured: Through study completion (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start17 Jan 2017
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Student WellnessStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Grace Connolly, Stanford University
- Investigators
- Sara G Cadman, MD, Principal investigator, Stanford University graduate, Penn Medicine Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039660
- Sponsor's protocol ID
- RefreshMD
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2017
- Last updated
- 17 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Online Curriculum to Improve Sleep in Medical Students: A Multisite Trial to Assess Efficacy and Feasibility of RefreshMD
- ClinicalTrials.gov ID
- NCT03039660
- Acronym / sponsor ID
- RefreshMD
- Conditions
- Student Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RefreshMD | Experimental | Behavioral: RefreshMDAn online course for sleep improvement in medical students |
| Bond Between Us | Placebo comparator | Behavioral: Bond Between UsAn online course covering communication skills and the physician-patient relationship |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Full-time medical student at a participating medical school
- Will remain enrolled as full-time medical student throughout duration of study
Key exclusion criteria (1 listed)
- Not a full-time medical student at a participating medical school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RefreshMDOnline Sleep Improvement Course | Behavioural | RefreshMD |
| Bond Between UsOnline Educational Course | Behavioural | Bond Between Us |
Primary outcome
Enrollment numbers per course
Time frame: 2 weeks
# of participants who enroll / # of participants invited to enroll
Views per video
Time frame: Throughout the course (6 weeks)
Number of actively engaged students per course
Time frame: Throughout the course (6 weeks)
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment
Time frame: Through study completion (4 months)
PROMIS Sleep Disturbance
Time frame: Through study completion (4 months)
PROMIS Depression
Time frame: Through study completion (4 months)
Stanford Medical Student Burnout Questionnaire
Time frame: Through study completion (4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara G Cadman, MD principal investigator
Stanford University graduate, Penn Medicine Fellow
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RefreshMD and Bond Between Us in people with Student Wellness, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment numbers per course (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.