Clinical trial NCT02302924: Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
Official title: Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Influenza-like Illness
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Evidera
name: Leidos Biomedical Research, Inc.
First posted: 2014-11-27
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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. The development of an instrument for participant reported outcomes of influenza was composed of three stages, as described below:

Stage I. Elicitation interviews in a group of volunteers with laboratory-confirmed influenza to inform the development of the instrument, including its content and structure (item phrasing, length, response options, recall).

Stage II. Evaluative interviews with a second set of volunteers with laboratory-confirmed influenza to assess comprehension and interpretability of the instrument and draft item pool from the respondent's perspective.

Stage III. Item reduction and instrument validation in a third set of volunteers to evaluate item properties and quantitatively validate the performance of the final measure.

This protocol will describe the rationale, design, data collection procedures, and analysis methods for Stage III - Item Reduction and Instrument Validation.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Madigan Army Medical Center
name: Mary Fairchok, MD
role: PRINCIPAL_INVESTIGATOR
References: