- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05537532
Intern Health Study 2021 (IHS 2021)
Intern Health Study: 2021 Micro-Randomized Trial
Study Overview
Status
Conditions
Detailed Description
Due to their high-stress workloads, medical interns tend to have lower sleep and decreased physical activity. The goal of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns. During the study, they are teamed up by programs and institutions and compete with other teams, which aim to motivate them to have more physical activity and sleep duration during their internship year.
The primary aim of this study is to investigate whether introducing competition mechanisms into mobile health (mHealth) interventions can improve a medical intern's activity-related behavioral outcomes: daily step counts and sleep duration. The first secondary aim is to assess the time-varying competition effect on their behavioral outcomes. The first exploratory aim is to assess the competition effect on study engagement and the second exploratory aim is to evaluate the competition effect on mental outcome, mood score.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical intern during the 2021-2022 internship year
- Enrolled in study by the start of internship (7/1/22)
Exclusion Criteria:
- None
Study Plan
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: Non-competition group
For each week, an eligible team is randomized to either competition or non-competition group with 50/50 chance.
|
The Intern Health Study mobile app is able to conduct a daily mood survey.
It also aggregates and visualizes historical data on intern mood, activity, and sleep.
|
Experimental: Competition group
Programs with at least five interns were grouped into program-based teams. Interns within the same residency institution in programs that did not meet this criterion were grouped into institution-based teams, with a minimum of five participants per team. For each week, an eligible team is randomized to either a steps competition or non-competition group with 50/50 chance. For those randomized to competition arm, teams were assigned an opponent team by total randomization, by which the opponent team was assigned regardless of institution and specialty. |
Participants will receive three types of push notifications: 1. Alert of competition type (steps or sleep) and opponent (Sunday 9pm), 2. Competition score status update (Wednesday 9pm, Saturday 11am), and 3. Competition final results (Monday 12pm).
The Intern Health Study mobile app is able to conduct a daily mood survey.
It also aggregates and visualizes historical data on intern mood, activity, and sleep.
Participant can view their current competition scoreboard and competition history at any time via the study app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average daily step count
Time Frame: Daily, throughout intern year (1 year)
|
Participants' daily step counts are recorded through a Fitbit or an apple watch. High step counts are considered a positive outcome as it indicates more physical activity. For teams randomized into competition arm and randomized to compete on step count, their average daily step count is compared with the average step count of the opponent team. |
Daily, throughout intern year (1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average daily mood score
Time Frame: Daily, throughout intern year (1 year)
|
Through the study mobile app, participants enter a mood score (scale 1-10) every day of the study. 1 corresponds to lowest mood and 10 corresponds to highest mood.
|
Daily, throughout intern year (1 year)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HUM00033029.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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