Home Testing of Respiratory Illness

NCT04245800 | Completed

• 1 other identifier: STUDY00008861
• Study Type: observational
• Target: 5,233
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this research study is to use data from activity trackers (such as Fitbits), lab tests, and surveys to see if activity, sleep, and heart rate data can tell the difference between when someone has a respiratory illness (e.g., flu) and when they are feeling healthy. The research will also study an investigational flu@home test and app. If successful, results from the study could be used in the future to better identify people with respiratory illness. In addition, this study will test the accuracy of an at-home flu test kit compared to laboratory test results.

Conditions

Influenza -Like Illness; Influenza A; Influenza Type B; Respiratory Viral Infection; Respiratory Tract Infections

Keywords

Influenza; self-testing; diagnostic accuracy

Outcome Measures

Primary Outcomes (3)

• Detection of RVI cases through the use of behavioral data and patient-reported outcomes

  Behavioral data from Fitbit wearables, patient self-reported data (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and diagnostics during flu or RVI episode

  End of month 4 (when data collection concludes)

• Database development of Influenza and/or other RVI confirmations collected during the 2019-2020 flu season.

  Behavioral data from Fitbit wearables, patient self-reported data (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and diagnostics during flu or RVI episode

  End of month 4 (when data collection concludes)

• Built, trained and tested analytical model for future real-time RVI surveillance systems

  Database comprised of behavioral data from Fitbit wearables, patient self-reported data (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and diagnostics during flu or RVI episode

  End of month 4 (when data collection concludes)

Secondary Outcomes (1)

• Comparative accuracy of flu@home RDT

  End of month 4 (when data collection concludes)

Study Arms (1)

Observational

All participants will be part of the prospective observational cohort. If participants develop flu-like symptoms, they will be prompted to complete the flu@home self-test kit. Analysis will be conducted for various subgroups (e.g. age, vaccination status)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living in the US

You may qualify if:

• Age 18 years or older
• Lives in the United States
• Speaks, reads, and understands English
• Owns a wearable Fitbit that collects heart rate data
• Willing to connect their Fitbit to the Achievement study platform and wear their Fitbit daily during the day and during sleep for the duration of the study
• Willing to respond to short daily questionnaires for a 4-month period
• Has an iOS or Android smartphone or tablet that is capable of supporting the Audere flu@home app
• Google Play Store compatible Android devices on Android 5.1 or later
• iOS devices on iOS 11 or later
• Willing to download the flu@home app
• Willing to complete an at-home flu test kit (via two nasal swabs) and return the nasal swab samples within 24 hours of being asked to complete a flu test kit

You may not qualify if:

• Diagnosed with flu by a healthcare professional in the past 3 months
• Currently enrolled in another flu study being conducted by Evidation Health/Achievement Studies

Sponsors & Collaborators

• Evidation Health: lead
• Audere: collaborator
• University of Washington: collaborator
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

Related Publications (20)

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  PMID: 18480225 BACKGROUND

• Bradshaw B, Konty KJ, Ramirez E, et al. 2019. Influenza surveillance using wearable mobile health devices, Online J Public Health Inform, 11:e249

  BACKGROUND

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  PMID: 29485018 BACKGROUND

• Dziabowska K, Czaczyk E, Nidzworski D. Detection Methods of Human and Animal Influenza Virus-Current Trends. Biosensors (Basel). 2018 Oct 18;8(4):94. doi: 10.3390/bios8040094.

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• Ebell MH, Afonso A. A systematic review of clinical decision rules for the diagnosis of influenza. Ann Fam Med. 2011 Jan-Feb;9(1):69-77. doi: 10.1370/afm.1192.

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• Ebell MH, Afonso AM, Gonzales R, Stein J, Genton B, Senn N. Development and validation of a clinical decision rule for the diagnosis of influenza. J Am Board Fam Med. 2012 Jan-Feb;25(1):55-62. doi: 10.3122/jabfm.2012.01.110161.

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• Kwon YS, Park SH, Kim MA, Kim HJ, Park JS, Lee MY, Lee CW, Dauti S, Choi WI. Risk of mortality associated with respiratory syncytial virus and influenza infection in adults. BMC Infect Dis. 2017 Dec 20;17(1):785. doi: 10.1186/s12879-017-2897-4.

  PMID: 29262784 BACKGROUND

• Larios OE, Coleman BL, Drews SJ, Mazzulli T, Borgundvaag B, Green K; STOP-Flu Study Group; McGeer AJ. Self-collected mid-turbinate swabs for the detection of respiratory viruses in adults with acute respiratory illnesses. PLoS One. 2011;6(6):e21335. doi: 10.1371/journal.pone.0021335. Epub 2011 Jun 23.

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• Pope LE, Hobbs CG. Epistaxis: an update on current management. Postgrad Med J. 2005 May;81(955):309-14. doi: 10.1136/pgmj.2004.025007.

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• Ross MH, Zick BL, Tsalik EL. Host-Based Diagnostics for Acute Respiratory Infections. Clin Ther. 2019 Oct;41(10):1923-1938. doi: 10.1016/j.clinthera.2019.06.007. Epub 2019 Jul 26.

  PMID: 31353133 BACKGROUND

• Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. JAMA. 2016 Nov 22;316(20):2115-2125. doi: 10.1001/jama.2016.16201.

  PMID: 27893129 BACKGROUND

• Smith SM, Sonego S, Wallen GR, Waterer G, Cheng AC, Thompson P. Use of non-pharmaceutical interventions to reduce the transmission of influenza in adults: A systematic review. Respirology. 2015 Aug;20(6):896-903. doi: 10.1111/resp.12541. Epub 2015 Apr 14.

  PMID: 25873071 BACKGROUND

• Uyeki TM, Bernstein HH, Bradley JS, Englund JA, File TM, Fry AM, Gravenstein S, Hayden FG, Harper SA, Hirshon JM, Ison MG, Johnston BL, Knight SL, McGeer A, Riley LE, Wolfe CR, Alexander PE, Pavia AT. Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenzaa. Clin Infect Dis. 2019 Mar 5;68(6):895-902. doi: 10.1093/cid/ciy874. No abstract available.

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• Hunter V, Shapiro A, Chawla D, Drawnel F, Ramirez E, Phillips E, Tadesse-Bell S, Foschini L, Ukachukwu V. Characterization of Influenza-Like Illness Burden Using Commercial Wearable Sensor Data and Patient-Reported Outcomes: Mixed Methods Cohort Study. J Med Internet Res. 2023 Mar 23;25:e41050. doi: 10.2196/41050.

  PMID: 36951890 DERIVED

Related Links

• CLIA Waiver for Quidel QuickVue Influenza A + B Test. (Part of flu@home kit)

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participants will collect a low nasal swab for PCR testing. The nasal swab will be mailed to a partner laboratory facility where the sample will be tested through PCR procedures for various RVIs. Immediate analysis will be done to identify iInfluenza A, influenza B, and respiratory syncytial virus (RSV). Samples will then be frozen, after which additional testing may be conducted to identify the presence of respiratory pathogens including adenovirus, coronavirus, human metapneumovirus, rhinovirus, and parainfluenza virus. No influenza or other RVI test results will be communicated back to the participant during their time in the study.

MeSH Terms

Conditions

Respiratory Tract Infections; Influenza, Human

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Matthew J Thompson, DPhil

  University of Washington

  STUDY DIRECTOR

• Jessie L Juusola, PhD

  Evidation Health

  PRINCIPAL INVESTIGATOR

• Ernesto Ramirez, PhD

  Evidation Health

  STUDY DIRECTOR

• Barry Lutz, PhD

  University of Washinton

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr Director, Health Outcomes Research

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: December 13, 2019
• Primary Completion: July 5, 2020
• Study Completion: July 6, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the end of month 4 (when data collection concludes)
• Access Criteria: Coded Study Data will be accessible by qualified researchers registered with the Synapse platform. The Synapse platform has rules to qualify researchers, and qualified researchers must register on Synapse, confirm their identity, and write a short statement about their research. The research could be about any topic. Researchers must sign an oath to use the data ethically and do no harm.

Locations

US (1)