Intern Health Study: 2020 Cohort Micro-Randomized Trial
1 other identifier
interventional
2,286
1 country
1
Brief Summary
The aim 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
October 22, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedNovember 3, 2021
October 1, 2021
1.2 years
October 22, 2021
October 22, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Average daily step count
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.
7 days
Average daily sleep minutes
Participant's nightly sleep duration (in minutes) is recorded through a Fitbit or an apple watch. High sleep duration is considered a positive outcome. For teams randomized into competition arm and randomized to compete on sleep duration, their average daily sleep minutes is compared with the average sleep minutes of the opponent team.
7 days
Secondary Outcomes (1)
Average daily mood score
7 days
Study Arms (2)
Competition arm
EXPERIMENTALPrograms 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 competition or non-competition group with 50/50 chance. For those randomized to competition arm, teams were assigned an opponent team according to a weekly equally randomly selected rule from three options: 1. total randomization, by which the opponent team was assigned regardless of institution and specialty; 2. within-institution randomization, by which two competing teams were from the same institution; 3. within-specialty randomization, by which two paired teams were from the same specialty. For each pair of competing teams, there was a 50/50 chance that they would compete on average daily step counts or average daily sleep minutes.
Non-competition group
EXPERIMENTALFor each week, an eligible team is randomized to either competition or non-competition group with 50/50 chance.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Medical intern during the 2020-2021 internship year
- Downloaded app, completed consent and filled out baseline survey prior to June 16th, 2020
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srijan Sen, M.D., Ph.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
October 22, 2021
First Posted
November 3, 2021
Study Start
April 1, 2020
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
November 3, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.
- Access Criteria
- The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.
De-identified genomic and survey information (baseline survey, plus quarterly survey which contains the PHQ-9) will be shared with the National Institute for Mental Health (NIMH).