Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04336020
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The DETECT(Digital Engagement & Tracking for Early Control, & Treatment) Study
Sponsor:
Scripps Translational Science Institute
Organization:
Study Overview
Official Title:
The DETECT (Digital Engagement & Tracking for Early Control, & Treatment) Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECT
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: