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FARD (RaDiCo Cohort) (RaDiCo-FARD)

Recruiting
Conditions
Incontinentia Pigmenti
Albinism
Palmoplantar Keratoderma
Inherited Epidermolysis Bullosa
Ectodermal Dysplasia
Neurofibromatosis Type 1
Pemphigus
Ichthyosis
Mucous Membrane Pemphigoid
Registration Number
NCT05954416
Lead Sponsor
Institut National de la Sant茅 Et de la Recherche M茅dicale, France
Brief Summary

The goal of this observational study is to conduct a prospective assessment of the individual Burden of 9 rare skin diseases to assess disability in the broadest sense of the term (psychological, social, economic and physical) for patients and/or families.

Two types of indicators will be used to reach this objective :

1. an individual burden score calculated based on a burden questionnaire created specifically, approved and designed to understand the tendency to changes in care and lifestyles. The burden questionnaire should be used by patients and/or their family themselves in self-assessment.

2. a descriptive analysis of all resources (medical and non-medical) used by the family unit to manage the disease.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
900
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Individual burden score for each selected rare diseaseThrough study completion, an average of 5 years

Before 16 years old, we will focus on the burden of families. After 16 years old, the patient's parent will continue to answer to the family Burden questionnaire and the patient will start to answer to the adult's Burden questionnaire.

Secondary Outcome Measures
NameTimeMethod
Description of calculated scores based on widely used survey completed by parentsThrough study completion, an average of 5 years
Descriptive analysis of the socio-economic Burden.Through study completion, an average of 5 years
Description of variations of quality-of-life scores.Through study completion, an average of 5 years
Validation of the clinical severity score for disease which have none at the beginning of the study and description of clinical severity score.Through study completion, an average of 5 years
Descriptive analysis of the Individual Health Care Cost.Through study completion, an average of 5 years
Search for association between individual burden score and clinical severity of the disease.Through study completion, an average of 5 years
Description of calculated scores based on widely used survey completed by patientsThrough study completion, an average of 5 years

Trial Locations

Locations (14)

H么pital Avicenne

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Bobigny, France

H么pital Dupuytren

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Limoges, France

H么pital Saint-Eloi

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Montpellier, France

H么pital l'Archet

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Nice, France

H么pital de la Timone

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Marseille, France

H么pital Robert-Debr茅

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Reims, France

H么pital Larrey

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Toulouse, France

H么pital Trousseau

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Tours, France

H么pital Charles Nicolle

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Rouen, France

H么pital des Enfants - Groupe Hospitalier Pellegrin

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Bordeaux, France

H么pital Henri-Mondor

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Cr茅teil, France

H么pital Fran莽ois Mitterrand

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Dijon, France

H么pital Necker-Enfants Malades

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Paris, France

H么pital Saint-Louis

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Paris, France

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