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

NCT02302924 | Completed

• 1 other identifier: IDCRP-081
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Influenza; Influenza-like Illness

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The targeted sample population will be recruited from the United States. Participants at the IDCRP sites will be both male and female military health care beneficiaries age 18 years and older presenting with the diagnosis of influenza or with influenza-like symptoms suggestive of infection.

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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Evidera: collaborator
• Leidos Biomedical Research, Inc.: collaborator

Study Sites (5)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

After obtaining informed consent, an oral/nasal swab or wash to confirm or rule out an influenza etiology will be collected at baseline if the participant does not already have documented laboratory confirmation of influenza.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Mary Fairchok, MD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 27, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

US (5)