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临床试验/NCT04245800
NCT04245800已完成不适用

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

Evidation Health1 个研究点 分布在 1 个国家目标入组 5,233 人开始时间: 2019年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,233
试验地点
1
主要终点
Detection of RVI cases through the use of behavioral data and patient-reported outcomes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

时间窗: 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

时间窗: 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

次要结局

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

研究者

发起方
Evidation Health
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Jessie Juusola

Sr Director, Health Outcomes Research

Evidation Health

研究点 (1)

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