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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza; Virus

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 Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: Lauren Ariniello, BS, CCRC; Phone Number: 858.784.2253; Email: laurena@scripps.edu
• Study Contact Backup: Name: Erin Coughlin; Email: coughlin@scripps.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • Scripps Research Translational Institute
      • Contact: Lauren Ariniello, BS, CCRC; Phone Number: 858-784-2253; Email: laurena@scripps.edu
      • Principal Investigator: Jennifer M Rading, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Investigators anticipate enrolling more than 100-thousand men and women in this study based on the inclusion criteria and otherwise no specific exclusion criteria.

Description

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:

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute
• Collaborators: CareEvolution Healthcare Technology
• Investigators: Principal Investigator: Jay Pandit, MD, Scripps Research Translational Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; Viral infections; influenza-like illnesses (ILI); participant-reported outcomes (PRO); electronic health record (EHR)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: IRB-20-7531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results of this research will be presented at meetings or in publication. However, the subject's identity will not be disclosed in those presentations.
• IPD Sharing Time Frame: Estimated 2025
• IPD Sharing Access Criteria: The results of this research will be presented at meetings or in publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No