A Virtual Prospective Study Exploring Activity Trackers and COVID-19 Infections
20 december 2021 uppdaterad av: Evidation Health
A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and SARS-CoV-2 Infection
Prospective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and SARS-CoV-2 infection
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
847
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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San Mateo, California, Förenta staterna, 94402
- Evidation Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adult participants (ages 18+) who reside in the contiguous United States and are at elevated risk of contracting COVID-19.
Beskrivning
Inclusion Criteria:
- Adults 18+ years of age
- Lives in the United States
- Speaks, reads, and understands English
- Willing and able to use and wear a wrist-worn activity device daily, during the day and during sleep, or as much as is possible, for the duration of the study
- Meets minimum software and device requirements for the wrist-worn activity device (Apple iOS 12 and up, Android version 6.0 and up)
- Willing to answer daily, weekly and monthly surveys for the duration of the study
- Willing to provide weekly self-collected saliva samples, plus one additional sample if prompted to do so (up to 9 total samples), and ship back the sample(s) within 24 hours of sample collection
Exclusion Criteria:
- Self-reported previous diagnosis of COVID-19
- Currently participating in any type of clinical trial
- Lives in the District of Columbia (Washington D.C.), Alaska, Hawaii, Arizona, Nevada, U.S. military base located overseas, or U.S. territories (Puerto Rico, U.S. Virgin Islands, Guam, Northern Mariana Island, or American Samoa)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Garmin Study Device Group
Individuals who are randomly assigned to receive the Garmin vívosmart® 4
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Empatica Study Device Group
Individuals who are randomly assigned to receive the Empatica E4
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection
Tidsram: Through study completion, an average of 7 months
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To develop a database of physiological and behavioral data via wearable devices and self-reported questionnaires (e.g.,symptoms) combined with laboratory confirmation of SARS- CoV-2 infection.
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Through study completion, an average of 7 months
|
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Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data
Tidsram: Through study completion, an average of 7 months
|
Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.
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Through study completion, an average of 7 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Lift of the analytical models as expressed as the ratio of COVID-19+ recall (COVID-19+ cases detected by model as a percentage of total positive cases)/Healthy false positives (healthy cases detected by the model as being COVID-19+).
Tidsram: Through study completion, an average of 7 months
|
Lift is a measure of model performance and will be evaluated at multiple timepoints along the infection time-course (for example, 1 day prior to illness onset, onset, day 3, etc.)
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Through study completion, an average of 7 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ernesto Ramirez, PhD, Evidation Health
- Huvudutredare: Luca Foschini, PhD, Evidation Health
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.
- Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11.
- Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.
- Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum In: JAMA. 2020 May 26;323(20):2098.
- CDC COVID-19 Response Team. Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 - United States, February 12-March 28, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):382-386. doi: 10.15585/mmwr.mm6913e2.
- Arons MM, Hatfield KM, Reddy SC, Kimball A, James A, Jacobs JR, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Dyal JW, Harney J, Chisty Z, Bell JM, Methner M, Paul P, Carlson CM, McLaughlin HP, Thornburg N, Tong S, Tamin A, Tao Y, Uehara A, Harcourt J, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Montgomery P, Stone ND, Clark TA, Honein MA, Duchin JS, Jernigan JA; Public Health-Seattle and King County and CDC COVID-19 Investigation Team. Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility. N Engl J Med. 2020 May 28;382(22):2081-2090. doi: 10.1056/NEJMoa2008457. Epub 2020 Apr 24.
- Chow EJ, Schwartz NG, Tobolowsky FA, Zacks RLT, Huntington-Frazier M, Reddy SC, Rao AK. Symptom Screening at Illness Onset of Health Care Personnel With SARS-CoV-2 Infection in King County, Washington. JAMA. 2020 May 26;323(20):2087-2089. doi: 10.1001/jama.2020.6637.
- Gandhi M, Yokoe DS, Havlir DV. Asymptomatic Transmission, the Achilles' Heel of Current Strategies to Control Covid-19. N Engl J Med. 2020 May 28;382(22):2158-2160. doi: 10.1056/NEJMe2009758. Epub 2020 Apr 24. No abstract available.
- Han C, Duan C, Zhang S, Spiegel B, Shi H, Wang W, Zhang L, Lin R, Liu J, Ding Z, Hou X. Digestive Symptoms in COVID-19 Patients With Mild Disease Severity: Clinical Presentation, Stool Viral RNA Testing, and Outcomes. Am J Gastroenterol. 2020 Jun;115(6):916-923. doi: 10.14309/ajg.0000000000000664.
- Poyiadji N, Shahin G, Noujaim D, Stone M, Patel S, Griffith B. COVID-19-associated Acute Hemorrhagic Necrotizing Encephalopathy: Imaging Features. Radiology. 2020 Aug;296(2):E119-E120. doi: 10.1148/radiol.2020201187. Epub 2020 Mar 31. No abstract available.
- Landa N, Mendieta-Eckert M, Fonda-Pascual P, Aguirre T. Chilblain-like lesions on feet and hands during the COVID-19 Pandemic. Int J Dermatol. 2020 Jun;59(6):739-743. doi: 10.1111/ijd.14937. Epub 2020 Apr 24. No abstract available.
- Grady, D. (2020, June 11). Covid-19 Patient Gets Double Lung Transplant, Offering Hope for Others. Retrieved from https://www.nytimes.com/2020/06/11/health/coronavirus-lung-transplant.html
- Grant MC, Geoghegan L, Arbyn M, Mohammed Z, McGuinness L, Clarke EL, Wade RG. The prevalence of symptoms in 24,410 adults infected by the novel coronavirus (SARS-CoV-2; COVID-19): A systematic review and meta-analysis of 148 studies from 9 countries. PLoS One. 2020 Jun 23;15(6):e0234765. doi: 10.1371/journal.pone.0234765. eCollection 2020.
- Marinsek N, Shapiro A, Clay I, et al. Measuring COVID-19 and Influenza in the Real World via Person-Generated Health Data. Published 2020 May 30. doi:10.1101/2020.05.28.20115964
- Auwaerter, PA. "Coronavirus COVID-19 (SARS-CoV-2)." Johns Hopkins ABX Guide, Johns Hopkins Medicine, 2020. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540 747/all/Coronavirus_COVID_19__SARS_CoV_2_#2
Användbara länkar
- Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV). (n.d.)
- COVID-19 Map. (n.d.)
- Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. (n.d.).
- Coronavirus disease 2019 (COVID-19) Situation Report - 73 (Issue brief No. 73).
- World Health Organization. (2020, April 1). COVID-19 - Virtual Press Conference [Press release].
- UCSF TemPredict Study. (n.d.).
- COVID-19 Wearables Study. (n.d.).
- Symptoms of Coronavirus. (2020, May 13)
- Phosphorus COVID-19 RT-QPCR Test - Letter of Authorization
- Oragene-Dx OGD-510
- Coronavirus Disease 2019 (COVID-19) 2020 Interim Case Definition, Approved April 5, 2020
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 november 2020
Primärt slutförande (Faktisk)
1 juni 2021
Avslutad studie (Faktisk)
1 juni 2021
Studieregistreringsdatum
Först inskickad
30 oktober 2020
Först inskickad som uppfyllde QC-kriterierna
6 november 2020
Första postat (Faktisk)
10 november 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 januari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 december 2021
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Luftvägsinfektioner
- Luftvägssjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Sjukdomsegenskaper
- Svår akut respiratorisk sjukdom
- Covid-19
- Infektioner
- Smittsamma sjukdomar
Andra studie-ID-nummer
- COVID Signals
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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