Clinical trial NCT04336020: The DETECT(Digital Engagement & Tracking for Early Control, & Treatment) Study
Official title: The DETECT (Digital Engagement & Tracking for Early Control, & Treatment) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza
Virus
Keywords: Influenza
Viral infections
influenza-like illnesses (ILI)
participant-reported outcomes (PRO)
electronic health record (EHR)
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: CareEvolution Healthcare Technology
First posted: 2020-04-07
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility 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:

Primary outcomes:
measure: 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.
timeFrame: Anticipated 2+-year duration of involvement in the study.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Research Translational Institute
state: California
Study officials:
affiliation: Scripps Research Translational Institute
name: Jay Pandit, MD
role: PRINCIPAL_INVESTIGATOR
References: