Clincosm LogoSign in Get a demo

FluPRO3: Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III

Sponsor
Uniformed Services University of the Health Sciences (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02302924
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), Evidera (Industry), Leidos Biomedical Research, Inc. (Industry)
535
Enrollment
5
Locations
8
Duration (Months)
107
Patients Per Site
13.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    535 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
    Study Start Date :
    Sep 1, 2014
    Actual Primary Completion Date :
    Mar 1, 2015
    Actual Study Completion Date :
    May 1, 2015

    Outcome Measures

    Primary Outcome Measures

    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. [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Naval Medical Center San Diego San Deigo 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
    5 Madigan Army Medical Center Tacoma Washington United States 98431

    Sponsors and Collaborators

    • Uniformed Services University of the Health Sciences
    • National Institute of Allergy and Infectious Diseases (NIAID)
    • Evidera
    • Leidos Biomedical Research, Inc.

    Investigators

    • Principal Investigator: Mary Fairchok, MD, Madigan Army Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uniformed Services University of the Health Sciences
    ClinicalTrials.gov Identifier:
    NCT02302924
    Other Study ID Numbers:
    • IDCRP-081
    First Posted:
    Nov 27, 2014
    Last Update Posted:
    Jun 12, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Influenza, Human

    Study Results

    No Results Posted as of Jun 12, 2015