Home Testing of Respiratory Illness

July 20, 2020 updated by: Jessie Juusola, Evidation Health

Behavioral Patterns and Patient Self-completed Diagnostic Testing Study of Respiratory Viral Infection "Home Testing of Respiratory Illness"

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Background and Rationale

Acute respiratory infections (ARI) cause considerable disease burden globally and can affect both the upper and lower respiratory tract. A majority of ARI are caused by viruses, like the influenza virus, while bacteria are only implicated in approximately 10% of cases . The symptomology across various viral ARI are broadly similar, but two viruses, namely influenza and respiratory syncytial virus (RSV) are associated with considerable morbidity and mortality among adults and children. More immediate virus identification would improve patient health management by triaging appropriate and timely treatment and infection-control measures to mitigate health costs, additional health complications, and total days of symptom expression.

Despite viral infections causing the majority of ARIs, 61% of those with acute respiratory symptoms receive an antibiotic treatment. Due to the rise of antibiotic resistance, the inappropriate and over-prescription of antibiotics has become a severe health risk and is contributing to greater health complications and increased mortality rates. As a result, the correct diagnosis of the various infections associated with ARIs has become even more imperative to not cause undue harm. The abundance, accessibility, and rapidly advancing technology in wearable devices contributes to the progress some studies have demonstrated in using the devices as a potential mechanism to more rapidly identify various diseases. Though limited research has explored this new perspective specifically in illnesses associated with ARI, recent findings were able to demonstrate influenza signals at a population level using step, sleep, and heart rate data collected from consumer wearable devices.

Influenza virus is important to diagnose correctly because, despite annual vaccinations, it has been associated with higher morbidity and mortality than most other ARI viruses and has been associated with greater individual symptom severity. During the 2017-2018 flu season in the United States, it was estimated that 48.8 million people became sick with influenza, 959,000 were hospitalized, and there were 79,400 deaths recorded due to influenza. Additionally, more vulnerable populations, like young children, those experiencing chronic illness, and older adults, disproportionately represent the hospitalization and death totals reported. Older adults represented 70% of influenza related hospitalizations in the 2017-2018 flu season and 90% of influenza related deaths.

The rapid diagnosis of influenza is also of particular importance due to the effectiveness of influenza antiviral medication that is largely limited to initiation within 48 hours of symptom onset. Additionally, rapid diagnosis also has the potential to enact infection control measures to attenuate viral spread, particularly among vulnerable populations, using behavioral interventions or other non-pharmaceutical approaches. Diagnosis of influenza infection in centralized laboratories has largely progressed from traditional viral culture to the use of reverse transcription-polymerase chain reaction (RT-PCR) methods . Alternatively, influenza infection can be detected within a medical office or pharmacy using commercially-available rapid diagnostic tests (RDTs) of varying complexity, cost and accuracy.

There is now interest to expand RDTs to self-conducted tests that individuals can complete at home to further reduce the period between the onset of illness and effective treatment. Audere, a digital health non-profit, developed a mobile device app, the flu@home app, to guide individuals to perform an influenza RDT themselves without being in a clinical setting. The flu@home test uses a mixture of images and written directions prompted through the flu@home app to walk individuals through an influenza RDT process. The flu@home test also includes modified influenza RDT test material from an FDA 510(k) cleared RDT and includes an optional in-app automated influenza RDT test result interpretation system to eventually help inform health decisions and behaviors. Though no research has been published on the efficacy of the flu@home system, it has been implemented, and is being investigated, in two large prospective observational clinical studies during the 2019-2020 flu season, with collaborators at the University of Washington, Seattle and University of Adelaide, Australia.

Expanding on the previous research and development that has been done, the aim of this study is to develop a methodology to better classify and detect RVI cases, including influenza, through the use of behavioral data and patient-reported outcomes, using RVI confirmation through laboratory testing as a reference. This study also aims to assess the accuracy of the flu@home RDT self-test, the in-app automated RDT test result interpretation, and a data enhanced RDT test interpretation, compared to the interpretation provided by a trained professional RDT reader, the PCR test result, and a reference influenza test interpretations/analysis.

Device Description

The flu@home test kit is an at-home self-administered modified influenza RDT that is completed with the assistance of a mobile device app. The flu@home app feature was developed by Audere, a digital health non-profit based in Seattle. The flu@home test consists of the instructional app experience that guides participants through the influenza RDT procedure and the physical material of the RDT influenza test kit modified from the Quidel QuickVue Influenza A+B test. The flu@home app will solely be utilized as an instructional guide and research data collection tool for this study.

The flu@home test kit's instructional app features are available on iOS and Android platforms. The instructional app features include multiple pages of text and imagery content guiding participants through the entirety of the influenza RDT process, from completing a nasal swab to adding solution into a test tube to run a lateral flow immunoassay. The instructional app also includes an in-app questionnaire for participants to complete during a 10-minute participant wait period while their immunoassay processes. The flu@home test kit also guides participants through the viral collection and appropriate transport procedure of study samples for additional RVI analysis to be completed at an accredited laboratory.

The physical material of the flu@home test kit consists of components from an existing commercial influenza RDT, with additional material to collect and return a reference sample for laboratory testing. The complete flu@home test kit includes two foam-tipped nasal swabs, a small tube with dried reagent, a saline vial, a lateral-flow immunoassay test strip, and a tube with liquid reagent for the PCR test. RDT testing material is utilized from the CLIA-waived Quidel QuickVue Influenza A+B Test. All physical testing material will be assembled and mailed to participants through a 3rd party vendor, Molecular Testing Lab (MTL). The flu@home test kit also includes mailing material for participants to return the RDT test remnant and strip to be discarded by MTL and the reference nasal swab for laboratory testing through PCR procedures at MTL's accredited facility.

The flu@home test kit's interpretation features will not be shared with participants within the parameters of this study.

Regulatory Status

The flu@home test kit is considered a non-significant investigational device that is being used for data collection purposes and will be labeled as an investigational device. The test kit contains foam-tipped nasal swabs, a small tube with dried reagent, a saline vial and test strip from the CLIA-waived Quidel QuickVue Influenza A+B Test, and a tube with liquid reagent for the PCR test.

Explanation of choice comparator

PCR (RT-PCR for RNA viruses including influenza) is a reliable reference test for influenza and other respiratory viruses. RT-PCR was identified as the comparator for the modified at-home self-administered influenza RDT. Though RDTs can produce results in a much shorter period of time than RT-PCRs, RT-PCRs have been found to have more sensitivity to the influenza viruses than do RDTs. PCR or RT-PCR is often used as the reference test in research studies and studies designed for FDA submission (e.g., influenza RT-PCR was used as a reference test in the FDA 510(k) submission for the Quidel QuickVue Influenza A+B Test; Quidel, 2018).

Study Type

Observational

Enrollment (Actual)

5233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94401
        • Evidation Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults living in the US

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of RVI cases through the use of behavioral data and patient-reported outcomes
Time Frame: End of month 4 (when data collection concludes)
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.
Time Frame: End of month 4 (when data collection concludes)
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
Time Frame: End of month 4 (when data collection concludes)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative accuracy of flu@home RDT
Time Frame: End of month 4 (when data collection concludes)
Comparative accuracy of the flu@home RDT self-test, the in-app automated RDT test result interpretation, and a data enhanced RDT test interpretation, compared to the interpretation provided by a trained professional RDT reader, the PCR test result, and reference influenza test interpretations/analysis.
End of month 4 (when data collection concludes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

University of Washington
Biomedical Advanced Research and Development Authority
Audere

Investigators

  • Study Director: Matthew J Thompson, DPhil, University of Washington
  • Study Director: Ernesto Ramirez, PhD, Evidation Health
  • Study Director: Barry Lutz, PhD, University of Washinton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 13, 2019

Primary Completion (ACTUAL)

July 5, 2020

Study Completion (ACTUAL)

July 6, 2020

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (ACTUAL)

January 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Coded Study Data may also be transferred to external research partners in accordance with IRB approved uses. Coded Study Data consists of all data collected within the parameters of this study, excluding any identifying information. After completion of the study, any potentially identifiable information will be removed and Coded Study Data will be made available to qualified researchers using the Synapse Platform run by Sage Bionetworks, a US-based non-profit focused on furthering scientific knowledge.

IPD Sharing Time Frame

At the end of month 4 (when data collection concludes)

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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