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

NCT ID: NCT04336020

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-24

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Influenza Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CareEvolution Healthcare Technology

UNKNOWN

Sponsor Role collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay Pandit, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Research Translational Institute

Locations

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Scripps Research Translational Institute

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Ariniello, BS, CCRC

Role: CONTACT

858.784.2253

Erin Coughlin

Role: CONTACT

Facility Contacts

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Lauren Ariniello, BS, CCRC

Role: primary

858-784-2253

References

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Radin JM, Vogel JM, Delgado F, Coughlin E, Gadaleta M, Pandit JA, Steinhubl SR. Long-term changes in wearable sensor data in people with and without Long Covid. NPJ Digit Med. 2024 Sep 13;7(1):246. doi: 10.1038/s41746-024-01238-x.

Reference Type DERIVED
PMID: 39271927 (View on PubMed)

Quer G, Coughlin E, Villacian J, Delgado F, Harris K, Verrant J, Gadaleta M, Hung TY, Ter Meer J, Radin JM, Ramos E, Adams M, Kim L, Chien JW, Baca-Motes K, Pandit JA, Talantov D, Steinhubl SR. Feasibility of wearable sensor signals and self-reported symptoms to prompt at-home testing for acute respiratory viruses in the USA (DETECT-AHEAD): a decentralised, randomised controlled trial. Lancet Digit Health. 2024 Aug;6(8):e546-e554. doi: 10.1016/S2589-7500(24)00096-7.

Reference Type DERIVED
PMID: 39059887 (View on PubMed)

Other Identifiers

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IRB-20-7531

Identifier Type: -

Identifier Source: org_study_id

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