Skip to main content
Clinical Trials/NCT04245800
NCT04245800CompletedNot Applicable

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

Evidation Health1 site in 1 country5,233 target enrollmentStarted: December 13, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
5,233
Locations
1
Primary Endpoint
Detection of RVI cases through the use of behavioral data and patient-reported outcomes

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Comparative accuracy of flu@home RDT(End of month 4 (when data collection concludes))

Investigators

Sponsor
Evidation Health
Sponsor Class
Industry
Responsible Party
Principal Investigator
Principal Investigator

Jessie Juusola

Sr Director, Health Outcomes Research

Evidation Health

Study Sites (1)

Loading locations...

Similar Trials