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

Influenza Clinical Trial

— DETECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04336020
• Other study ID #: IRB-20-7531
• Status: Recruiting
• Start date: March 24, 2020
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Scripps Translational Science Institute
• Contact: Lauren Ariniello, BS, CCRC
• Phone: 858.784.2253
• Email: laurena[@]scripps.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Virus

Locations

Country	Name	City	State
United States	Scripps Research Translational Institute	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	CareEvolution Healthcare Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Anticipated 2+-year duration of involvement in the study.