Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
Completed
Conditions studied: Influenza, Influenza-like Illness
In brief
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 validity would have value for public health in terms of use as a validated outcome measure in interventions to treat or prevent influenza. The instrument also could serve as part of an overall measure of severity of illness in influenza. Previous efforts in participant reported outcomes (PRO) for influenza (i.e. Flu-PRO Stage I and Stage II) focused on the elicitation and evaluation of items for inclusion in the instrument. The overarching objective of this protocol - Flu-PRO Stage III - is to conduct instrument validation to evaluate item properties and, if need be, reduce the number of items, and quantitatively validate the performance of the final measure.
Key facts
- Study ID
- NCT02302924
- Run by
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- People needed
- 535
- Starts
- 2014-09-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2023-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Naval Medical Center San Diego — San Diego, California, United States
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Brooke Army Medical Center — San Antonio, Texas, United States
- Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
- Madigan Army Medical Center — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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