InfluenzaDETECTNCT04336020
The DETECT(Digital Engagement & Tracking for Early Control, & Treatment) Study
An observational study of Influenza and Virus, run by Scripps Translational Science Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Erin Coughlin contact
United States1 site, 1 recruiting
- Recruiting
Scripps Research Translational Institute
San Diego, California, 92037
Lauren Ariniello, BS, CCRC, 858-784-2253, laurena@scripps.edu
Jennifer M Rading, PhD, MPH
About this study
Official title: 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.
Read the 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
- Keywords
- Influenza, Viral infections, influenza-like illnesses (ILI), participant-reported outcomes (PRO), electronic health record (EHR)
- Medical subject headings
- Influenza, Human, Virus Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Anticipated 2+-year duration of involvement in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start24 Mar 2020
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- CareEvolution Healthcare Technology
- Responsible party
- Sponsor
- Investigators
- Jay Pandit, MD, Principal investigator, Scripps Research Translational Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336020
- Sponsor's protocol ID
- IRB-20-7531
- Acronym
- DETECT
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39271927Quer 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.
PubMed 39059887
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DETECT (Digital Engagement & Tracking for Early Control, & Treatment) Study
- ClinicalTrials.gov ID
- NCT04336020
- Acronym / sponsor ID
- DETECT / IRB-20-7531
- Keywords
- Influenza, Viral infections, influenza-like illnesses (ILI), participant-reported outcomes (PRO), electronic health record (EHR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- CareEvolution Healthcare Technology
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39271927Radin 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.
- Derived from this study: PubMed 39059887Quer 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Coughlin contact
Jay Pandit, MD principal investigator
Scripps Research Translational Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Virus, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Ariniello, BS, CCRC (858.784.2253, laurena@scripps.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Anticipated 2+-year duration of involvement in the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336020, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.