Influenza Clinical Trial
— FluPRO3Official title:
Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
NCT number | NCT02302924 |
Other study ID # | IDCRP-081 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | May 2015 |
Verified date | February 2023 |
Source | Henry M. Jackson Foundation for the Advancement of Military Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 535 |
Est. completion date | May 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Naval Medical Center Portsmouth | Portsmouth | Virginia |
United States | Brooke Army Medical Center | San Antonio | Texas |
United States | Naval Medical Center San Diego | San Diego | California |
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Henry M. Jackson Foundation for the Advancement of Military Medicine | Evidera, Leidos Biomedical Research, Inc., National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The purpose of Flu-PRO Stage III is to conduct a quantitative validation of the FLU-PRO instrument to assess its performance as a standardized method to evaluate symptoms of influenza in natural history studies and clinical trials. | The study will utilize a prospective design to enroll participants with laboratory-confirmed influenza and to capture information regarding the severity of symptoms. This data will be used to validate the Flu-PRO instrument. | 1 year |
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