TelemedicineNCT05106439
Intern Health Study: 2020 Cohort Micro-Randomized Trial
A study testing Intern Health Study competition-related mobile notification, Intern Health Study mobile app and Intern Health Study mobile app competition scoreboard and history in people with Telemedicine, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Intern Health Study competition-related mobile notification, Intern Health Study mobile app and Intern Health Study mobile app competition scoreboard and history
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,286 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 30 Jun 2021
- 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
- Medical intern during the 2020-2021 internship year
- Downloaded app, completed consent and filled out baseline survey prior to June 16th, 2020
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Telemedicine
- Being tested
- Intern Health Study competition-related mobile notification, Intern Health Study mobile app, Intern Health Study mobile app competition scoreboard and history
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intern Health Study competition-related mobile notificationBehavioural
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).
Intern Health Study mobile appBehavioural
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.
Intern Health Study mobile app competition scoreboard and historyBehavioural
Participant can view their current competition scoreboard and competition history at any time via the study app.
| Study group | Role | What they receive |
|---|---|---|
| Competition arm | Experimental | 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. Receives: Behavioral: Intern Health Study competition-related mobile notification; Behavioral: Intern Health Study mobile app; Behavioral: Intern Health Study mobile app competition scoreboard and history |
| Non-competition group | Experimental | For each week, an eligible team is randomized to either competition or non-competition group with 50/50 chance. Receives: Behavioral: Intern Health Study mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days
Secondary outcomes (1)
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Apr 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Model description
- Randomization scheme
- Masking
- None (open label)
- Enrolment
- 2,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srijan Sen, University of Michigan
- Investigators
- Srijan Sen, M.D., Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106439
- Sponsor's protocol ID
- HUM00033029.20
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intern Health Study: 2020 Cohort Micro-Randomized Trial
- ClinicalTrials.gov ID
- NCT05106439
- Acronym / sponsor ID
- HUM00033029.20
- Conditions
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,286 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization scheme
| Arm | Type | Receives |
|---|---|---|
| Competition arm | Experimental | Behavioral: Intern Health Study competition-related mobile notification, Behavioral: Intern Health Study mobile app, Behavioral: Intern Health Study mobile app competition scoreboard and historyPrograms 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 | Experimental | Behavioral: Intern Health Study mobile appFor each week, an eligible team is randomized to either competition or non-competition group with 50/50 chance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical intern during the 2020-2021 internship year
- Downloaded app, completed consent and filled out baseline survey prior to June 16th, 2020
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Intern Health Study competition-related mobile notificationParticipants 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). | Behavioural | Competition arm |
| Intern Health Study mobile appThe 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. | Behavioural | Competition arm, Non-competition group |
| Intern Health Study mobile app competition scoreboard and historyParticipant can view their current competition scoreboard and competition history at any time via the study app. | Behavioural | Competition arm |
Primary outcome
Average daily step count
Time frame: 7 days
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.
Average daily sleep minutes
Time frame: 7 days
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.
1 secondary outcome
Average daily mood score
Time frame: 7 days
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 3 Nov 2021.
- Individual participant dataSharing planned: Yes. 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).
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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.
Srijan Sen, M.D., Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intern Health Study competition-related mobile notification, Intern Health Study mobile app and Intern Health Study mobile app competition scoreboard and history in people with Telemedicine, run by University of Michigan at 1 site 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Average daily step count (time frame: 7 days). The study lists 2 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 3 Nov 2021.