The DETECT(Digital Engagement & Tracking for Early Control, & Treatment) Study

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04336020
Collaborator
CareEvolution Healthcare Technology (Other)
100,000
1
60.3
1659.6

Study Details

Study Description

Brief Summary

Develop an app-based nationwide study of individuals who routinely use a smartwatch or other wearable activity tracker to determine if individualized tracking of changes in heart rate, activity and sleep can provide an early indication of influenza-like illnesses (ILI) and possibly other viral infections.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will be configured in CareEvolution's myDataHelps platform. This app-based platform will allow people to:

    • Provide informed consent electronically

    • Donate robust smartwatch and activity tracker data, as well as self-reported data.

    • Sensor-collected data, which will vary between devices, but what is shared will always be entirely up to the participant. Investigators anticipate a minimum to include heart rate and activity, plus sleep duration when available.

    • This can include historical data collected by a sensor prior to the participants date of joining the study.

    • Occasional survey-based participant-reported outcomes (PROs).

    • Participant-entered physiologic data such as oral temperature

    • Passively share environmental data such as air quality and weather that will be captured from external sources based on participants' "home" zip code. Optionally, if the participant consents to enable location/GPS services on their smartphone, higher grain environmental data will be enabled.

    • Optionally connect to and share their electronic health record (EHR) data in the event they have an event that requires interaction with a health care provider

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The DETECT (Digital Engagement & Tracking for Early Control, & Treatment) Study
    Actual Study Start Date :
    Mar 24, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. The primary objective of the study is to study the individual heart rate, activity and sleep data in identifying influenza-like illnesses (ILI) in that individual using the CareEvolution's myDataHelps app-based platform. [Anticipated 2+-year duration of involvement in the study.]

      The study will enable tens- to hundreds-of-thousands of interested smartwatch and active tracker wearers (e.g., Fitbit, Apple Watch, Garmin, Amazefit, OURA, Beddit, etc.) to donate their routinely collected data for research through a user-friendly app-based research platform to determine if individualized tracking of changes in heart rate, activity and sleep can provide an early indication of influenza-like illnesses (ILI) and possibly other viral infections. The study will capture timing, symptoms, and treatments of influenza-like illnesses (ILI) through on-app participant-reported outcome (PROs). When possible, use electronic health records (EHR) , available through in-app linkage, to supplement PRO-collected information about ILI or similar episodes. Data from optional devices (pulse ox, weight scales, BP cuffs, glucometers) may be integrated if the devices are connected and participant consents to share their data.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Living in the U.S.

    • 18 years or older

    • Android or iPhone Smartphone user

    • Any connected wearable (Apple Watch, Fitbit, Garmin watch connected to Apple Health or Google Fit, Amazfit)

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Research Translational Institute San Diego California United States 92037

    Sponsors and Collaborators

    • Scripps Translational Science Institute
    • CareEvolution Healthcare Technology

    Investigators

    • Principal Investigator: Jennifer M Radin, PhD, MPH, Scripps Research Translational Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Scripps Translational Science Institute
    ClinicalTrials.gov Identifier:
    NCT04336020
    Other Study ID Numbers:
    • IRB-20-7531
    First Posted:
    Apr 7, 2020
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Scripps Translational Science Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 15, 2022