InfluenzaFluPRO3NCT02302924
Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
An observational study of Influenza and Influenza-like Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza-like Illness
- How many people
- 535 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Brooke Army Medical Center
San Antonio, Texas, 78234
Naval Medical Center San Diego
San Diego, California, 92134
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
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.
Read the 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.
- Conditions
- Influenza, Influenza-like Illness
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Evidera, Leidos Biomedical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Mary Fairchok, MD, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302924
- Sponsor's protocol ID
- IDCRP-081
- Acronym
- FluPRO3
- Status last verified
- Feb 2023
- First submitted
- 24 Nov 2014
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psychometric Testing Properties of Severity Symptom Grading Scale of Influenza Infection: Flu-PRO Stage III
- ClinicalTrials.gov ID
- NCT02302924
- Acronym / sponsor ID
- FluPRO3 / IDCRP-081
- Conditions
- Influenza, Influenza-like Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Evidera, Leidos Biomedical Research, Inc.
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- DEERS eligible
- Adults ≥18 years
- Influenza or influenza-like symptoms as defined by one or more of the following:
- Speak and read English
- Access to the internet through computer, laptop, tablet, or smartphone
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Fairchok, MD principal investigator
Madigan Army Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Influenza-like Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.