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

NCT04336020 | Recruiting

• 1 other identifier: IRB-20-7531
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Virus

Keywords

Influenza; Viral infections; influenza-like illnesses (ILI); participant-reported outcomes (PRO); electronic health record (EHR)

Outcome Measures

Primary Outcomes (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.

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Living in the U.S.
• years or older
• Android or iPhone Smartphone user
• Any connected wearable (Apple Watch, Fitbit, Garmin watch connected to Apple Health or Google Fit, Amazfit)

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• CareEvolution Healthcare Technology: collaborator

Study Sites (1)

Scripps Research Translational Institute

San Diego, California, 92037, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 39271927 DERIVED

• 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.

  PMID: 39059887 DERIVED

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Officials

• Jay Pandit, MD

  Scripps Research Translational Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Ariniello, BS, CCRC

CONTACT

858.784.2253; laurena@scripps.edu

Erin Coughlin

CONTACT

coughlin@scripps.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: March 24, 2020
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Estimated 2025
• Access Criteria: The results of this research will be presented at meetings or in publication.

Locations

US (1)