Life Quality Study for PFAPA Patient (PFAPA)
February 6, 2023 updated by: Véronique Hentgen, Versailles Hospital
This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.
Study Overview
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Le Chesnay, France
- Centre Hospitalier De Versailles
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Paris, France
- CH de Bicêtre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with PFAPA syndrome compare to patient with FMF syndrome
Description
Inclusion Criteria:
- PFAPA syndrome patients or FMF patients
Exclusion Criteria:
- Participation refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PFAPA group
Life quality for PFAPA patient report by themselves or parent
|
Quality of life
|
|
FMF group
Life quality for FMF patient report by themselves or parent
|
Quality of life
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
April 1, 2017
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (ESTIMATE)
June 23, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- P15/13_PFAPA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.