Mobile App Notifications for Intern Health

(IHS Trial)

Overseen By Srijan Sen, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Intern Health Study behavioral change mobile notification?

Research shows that mobile health apps and text message interventions can effectively promote behavioral changes and improve health outcomes, such as weight loss and appointment adherence, suggesting potential benefits for intern health through similar mobile notifications. ^{1 2 3 4 5}

Is the mobile app notification system for intern health generally safe for humans?

The research on mobile apps for reporting adverse events, particularly after vaccinations, suggests that these apps are generally well-accepted and safe to use. They have been shown to increase reporting rates and are considered a suitable supplement for monitoring health events. ^{6 7 8 9 10}

How is the Intern Health Study behavioral change mobile notification treatment different from other treatments?

The Intern Health Study's mobile notification treatment is unique because it uses behavior change notifications delivered through a mobile app to support intern health, focusing on timing and content to enhance engagement. This approach is distinct from traditional treatments as it leverages technology to provide timely, personalized prompts that encourage healthy behaviors, similar to just-in-time adaptive interventions (JITAIs) used in other health contexts. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for medical interns in the 2024-2025 year who have an iPhone or Android phone. They must join the Intern Health Study by logging into a mobile app, consenting to participate, and completing a baseline survey before June.

Inclusion Criteria

Logged into the Intern Health Study mobile app, completed consent, and filled out baseline survey by June 30 prior to the start of intern year

Medical intern during the 2024-2025 internship year

iPhone or Android phone user

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive mobile phone notifications to improve mood, physical activity, and sleep

1 year

Daily notifications

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Intern Health Study behavioral change mobile notification

Trial Overview The study tests whether receiving behavioral change notifications on a smartphone can improve mood, increase physical activity, and enhance sleep quality among medical interns.

Participant Groups

Group I: Within-participant micro-randomization Experimental Treatment 1 Intervention

Each day in the study, with probability .5 for each, a participant is randomized to receive a notification that day or no notification that day. If a participant is assigned to receive a notification that day, 1 message set will be randomly selected from a pool of 358 core message sets. Each core message set will be comprised of 4 messages containing comparable content, however they will be tailored based on the participant's wearable (steps, sleep) or mood data for the specified time interval (7 days, 30 days, since the start of internship) as follows: 1) no data, 2) low, 3) moderate, or 4) high.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

A review of 6 systematic reviews identified only 22 stand-alone mobile health apps that have been evaluated in randomized controlled trials (RCTs), primarily focusing on diabetes, mental health, and obesity.

While 11 out of 23 trials showed meaningful health benefits from these apps, the overall quality of evidence was low due to small sample sizes and high risk of bias, indicating a need for more rigorous studies before these apps can be widely prescribed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribable mHealth apps identified from an overview of systematic reviews. Byambasuren, O., Sanders, S., Beller, E., et al.[2020]

A systematic review of nutrition apps found that while they can lead to increased adherence to diet monitoring and some weight loss advantages, the evidence is limited, with only four studies meeting the inclusion criteria.

Most studies focused on weight loss rather than improving nutrition knowledge, and the outcomes were inconsistent, indicating a need for further research that incorporates behavioral theories into app design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of mobile apps to improve nutrition outcomes: A systematic literature review. DiFilippo, KN., Huang, WH., Andrade, JE., et al.[2022]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

The STARSS trial, involving 6,338 participants, showed that using SMS prompts for reporting adverse events following immunization (AEFI) significantly improved detection rates, with a 13-fold increase in AEFI detection compared to traditional methods.

Out of the SMS group, 184 verified AEFIs were reported, while only 6 were reported in the control group, highlighting the efficacy of mobile health technology in enhancing vaccine safety surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Cashman, P., et al.[2021]

A mobile app was developed to facilitate reporting of adverse events following immunization (AEFI) for the influenza vaccine, and it successfully recorded 1104 data points from 38 participants, indicating its feasibility for AEFI reporting.

Despite the app's success in data collection, only 63% of participants downloaded it, and only 28% reported new or worsening health conditions after vaccination, suggesting barriers to wider adoption that need to be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. Wilson, K., Atkinson, KM., Westeinde, J., et al.[2022]

The study involved 86 participants who contributed to the development of tailored notifications for a mobile health intervention aimed at reducing sodium intake and increasing physical activity to lower blood pressure.

Community-generated notifications were found to be more effective, using direct and relatable language, while also addressing specific cultural and social needs, highlighting the importance of incorporating local perspectives in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community Participatory Approach to Creating Contextually Tailored mHealth Notifications: myBPmyLife Project. Hellem, AK., Casetti, A., Bowie, K., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Prescribable mHealth apps identified from an overview of systematic reviews. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Implementation of a text message intervention to promote behavioural change and weight loss among overweight and obese Brazilian primary care patients. [2022]

3. Egypt pubmed.ncbi.nlm.nih.gov

Text Message Reminders Increase Appointment Adherence in a Pediatric Clinic: A Randomized Controlled Trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The use of mobile apps to improve nutrition outcomes: A systematic literature review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Smartphone Application for Teamwork and Communication in Trauma: Pilot Evaluation "in the Wild". [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

7. Australia pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Introduction of a Mobile Adverse Event Reporting System Is Associated With Participation in Adverse Event Reporting. [2020]

11. Canada pubmed.ncbi.nlm.nih.gov

Notifications to Improve Engagement With an Alcohol Reduction App: Protocol for a Micro-Randomized Trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

From hybrid to fully remote clinical trial amidst the COVID-19 pandemic: Strategies to promote recruitment, retention, and engagement in a randomized mHealth trial. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Rams Have Heart, a Mobile App Tracking Activity and Fruit and Vegetable Consumption to Support the Cardiovascular Health of College Students: Development and Usability Study. [2021]

14. England pubmed.ncbi.nlm.nih.gov

StudyMe: a new mobile app for user-centric N-of-1 trials. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

A Community Participatory Approach to Creating Contextually Tailored mHealth Notifications: myBPmyLife Project. [2023]