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

Recruiting

• Conditions: Virus; Influenza

• Registration Number: NCT04336020
• Lead Sponsor: Scripps Translational Science Institute

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.

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 Timeline

• Study Start: 2020-03-24
• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Scripps Research Translational Institute; 🇺🇸 San Diego, California, United States