NCT04623047

Brief Summary

This study will reach out to patients who have undergone diagnostic testing for the following respiratory illnesses from January 1st, 2018 to July 9th, 2023: COVID-19, Influenza, Rhinovirus, and Respiratory Syncytial Virus. This study aims to develop a forecasting model to predict infection onset prior to symptom onset using wearable device data and known symptom onset and test dates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,034

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

November 9, 2020

Last Update Submit

June 28, 2024

Conditions

Keywords

Wearable DeviceSmart Watch

Outcome Measures

Primary Outcomes (1)

  • Develop a forecasting model to predict infection onset prior to symptom onset using the amount of time between known symptom onset and test dates

    Known symptom onset and test dates will serve to validate the model

    18 Months

Secondary Outcomes (6)

  • Determine if there are signal differences that can differentiate the type of respiratory infection (e.g., COVID-19 vs. Influenza)

    18 Months

  • Percentage of missingness in the wearable device data

    18 Months

  • Determine the performance of the forecasting model on a new viral strain through transfer learning

    18 Months

  • Determine if there are physiological differences between initial infection and reinfection

    18 Months

  • Determine if there are physiological differences between varying respiratory infections over time

    18 Months

  • +1 more secondary outcomes

Study Arms (1)

Adults 18 years of age and up

The study will recruit any adult over the age of 18 years.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults age 18 years of age and older

You may qualify if:

  • years of age and older

You may not qualify if:

  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Chris Woods

    Duke University

    PRINCIPAL INVESTIGATOR
  • Jessilyn Dunn

    Duke University

    PRINCIPAL INVESTIGATOR
  • Ryan Shaw

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 10, 2020

Study Start

June 28, 2023

Primary Completion

June 15, 2024

Study Completion

June 15, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations