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Life Quality Study for PFAPA Patient (PFAPA)

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ClinicalTrials.gov Identifier: NCT02811705
Recruitment Status : Unknown
Verified June 2016 by Véronique Hentgen, Versailles Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Véronique Hentgen, Versailles Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
PFAPA Syndrome Other: Quality of life

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
PFAPA group
Life quality for PFAPA patient report by themselves or parent
 Other: Quality of life
Quality of life
FMF group
Life quality for FMF patient report by themselves or parent
 Other: Quality of life
Quality of life


Outcome Measures
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Primary Outcome Measures :
  1. Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with PFAPA syndrome compare to patient with FMF syndrome
Criteria

Inclusion Criteria:

  • PFAPA syndrome patients or FMF patients

Exclusion Criteria:

  • Participation refusal
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811705


Contacts
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Contact: Laure Morisset lmorisset@ch-versailles.fr

Locations
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France
Centre hospitalier de Versailles Recruiting
Le Chesnay, France
Contact: Veronique Hentgen         
CH de Bicètre Recruiting
Paris, France
Sponsors and Collaborators
Versailles Hospital
More Information
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Responsible Party: Véronique Hentgen, Dr, Versailles Hospital
ClinicalTrials.gov Identifier: NCT02811705    
Other Study ID Numbers: P15/13_PFAPA
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016