Quality of Life in Patients With Auto-inflammatory Diseases

NCT03569644 | Completed

• 2 other identifiers: K160903J2017-A02673-50
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

This qualitative interview-based study aim to build a tool to assess quality of life in patients (adults or children) suffering from 6 autoinflammatory diseases (FMF, TRAPS, CAPS, MKD, Still and PFAPA).

Conditions

Hereditary Autoinflammatory Diseases

Outcome Measures

Primary Outcomes (1)

• Qualitative evaluation of quality of life by interviews of patients and/or parents

  The interviews will be recorded in digital audio and then transcribed literally. The analysis will be phenomenological. Four age group will be interviewed : \< 6 year-old (parents), 6 to 12 year-old (patients and parents) , 13 to 17 year-old (patients and parents) , \> 18 year-old (patients)

  45 to 90 min

Study Arms (1)

qualitative study

OTHER

heterogeneous group of patients

Other: qualitative study

Interventions

qualitative study OTHER

Interviews

qualitative study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient (child and adult) with one of the 6 AIDs (FMF, TRAPS, MKD or CAPS, PFAPA or Still's disease) regardless of the activity of the disease. The diagnosis will have been made by the referring physician according to criteria specific to each AIDs
• Volunteer to participate in the study
• With at least one parent present at the consultation if it is a child under 18 years old
• For minors, agreement of the parents or their legal representative or one of the present parents
• Information for children as far as their age and condition allow
• Affiliation to a national health insurance.

You may not qualify if:

• patient or relative (according to age)refuse to participate.
• Bad understanding of French.
• Other chronic inflammatory pathology associated (example: Crohn's, SPA, uveitis, psoriasis ...)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

CH André Mignot

Le Chesnay, France, 78150, France

Location

TENON

Paris, Paris, 75020, France

Location

Dr Maryam PIRAM

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Hereditary Autoinflammatory Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is based on interviews that will be recorded in digital audio and then transcribed literally. The consultation for this research is 45 to 90 minutes long. This prolongs their presence in consultation with the doctor. For this reason, the study was classified as Interventional according to French regulations

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: June 6, 2018
• Primary Completion: November 6, 2019
• Study Completion: April 1, 2021
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (3)