Status:

COMPLETED

Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III

Lead Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborating Sponsors:

National Institute of Allergy and Infectious Diseases (NIAID)

Evidera

Conditions:

Influenza

Influenza-like Illness

Eligibility:

All Genders

18+ years

Brief Summary

There is no standardized method for evaluating the symptoms of influenza. A standardized instrument for measuring influenza symptoms, with appropriate scientifically derived content and construct vali...

Detailed Description

The overarching purpose of this study is to develop a single, standardized measurement scale of participant influenza symptoms for use in clinical studies involving adult and pediatric participants. T...

Eligibility Criteria

Inclusion

  • DEERS eligible
  • Adults ≥18 years
  • Influenza or influenza-like symptoms as defined by one or more of the following:
  • Positive influenza test by PCR, culture, and/or rapid antigen testing
  • Fever with temperature ≥100.4° F \[38° C\] AND Respiratory Symptoms\* OR
  • Subjective fever AND Respiratory Symptoms\* \[\*Respiratory Symptoms: cough, or sputum production, or shortness of breath, or chest pain, and/or sore throat\]
  • Speak and read English
  • Access to the internet through computer, laptop, tablet, or smartphone

Exclusion

  • Individuals who do not have access to the internet by computer, laptop, tablet, or smartphone
  • Individuals with cognitive and/or physical disabilities who are unable to use a touch screen or computer mouse to enter information into an internet-based survey

Key Trial Info

Start Date :

September 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2015

Estimated Enrollment :

535 Patients enrolled

Trial Details

Trial ID

NCT02302924

Start Date

September 1 2014

End Date

May 1 2015

Last Update

February 3 2023

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Naval Medical Center San Diego

San Diego, California, United States, 92134

2

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20814

3

Brooke Army Medical Center

San Antonio, Texas, United States, 78234

4

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States, 23708