Intern Health Study: 2020 Cohort Micro-Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Telemedicine
• Intervention / Treatment: Behavioral: Intern Health Study competition-related mobile notification; Behavioral: Intern Health Study mobile app; Behavioral: Intern Health Study mobile app competition scoreboard and history

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 competes 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 second secondary aim is to evaluate how social cooperation (competing within the same institution or program) moderates the effect of competition on 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: Interventional
• Enrollment (Actual): 2286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan, Ann Arbor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medical intern during the 2020-2021 internship year
• Downloaded app, completed consent and filled out baseline survey prior to June 16th, 2020

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Competition arm; 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 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.	Behavioral: Intern Health Study competition-related mobile notification; 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).; Behavioral: Intern Health Study mobile app; 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.; Behavioral: Intern Health Study mobile app competition scoreboard and history; Participant can view their current competition scoreboard and competition history at any time via the study app.
Experimental: Non-competition group; For each week, an eligible team is randomized to either competition or non-competition group with 50/50 chance.	Behavioral: Intern Health Study mobile app; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily mood score	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	7 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Srijan Sen, M.D., Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HUM00033029.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.
• IPD Sharing Access Criteria: The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No