Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336020
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
CareEvolution Healthcare Technology
Information provided by (Responsible Party):
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.

Condition or disease
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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The DETECT (Digital Engagement & Tracking for Early Control, & Treatment) Study
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot




Primary Outcome Measures :
  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. [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336020


Contacts
Layout table for location contacts
Contact: Lauren Ariniello, BS, CCRC 858.784.2253 laurena@scripps.edu
Contact: Gail S Ebner, BS 858.784.2051 gsebner@scripps.edu

Locations
Layout table for location information
United States, California
Scripps Research Translational Institute Recruiting
San Diego, California, United States, 92037
Contact: Lauren Ariniello, BS, CCRC    858-784-2253    laurena@scripps.edu   
Principal Investigator: Jennifer M Rading, PhD, MPH         
Sponsors and Collaborators
Scripps Translational Science Institute
CareEvolution Healthcare Technology
Investigators
Layout table for investigator information
Principal Investigator: Jennifer M Radin, PhD, MPH Scripps Research Translational Institute
Layout table for additonal information
Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT04336020    
Other Study ID Numbers: IRB-20-7531
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Estimated 2025
Access Criteria: The results of this research will be presented at meetings or in publication.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scripps Translational Science Institute:
Influenza
Viral infections
influenza-like illnesses (ILI)
participant-reported outcomes (PRO)
electronic health record (EHR)
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases