The DETECT(Digital Engagement & Tracking for Early Control, & Treatment) Study (DETECT)
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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 |
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Recruitment Status :
Recruiting
First Posted : April 7, 2020
Last Update Posted : April 8, 2021
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| Condition or disease |
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| Influenza Virus |
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.
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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 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 |
- 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.
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.
| 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 |
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:
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
| Contact: Lauren Ariniello, BS, CCRC | 858.784.2253 | laurena@scripps.edu | |
| Contact: Gail S Ebner, BS | 858.784.2051 | gsebner@scripps.edu |
| 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 | |
| Principal Investigator: | Jennifer M Radin, PhD, MPH | Scripps Research Translational Institute |
| 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 8, 2021 |
| Last Verified: | March 2021 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Influenza Viral infections influenza-like illnesses (ILI) participant-reported outcomes (PRO) electronic health record (EHR) |
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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |