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Clinical Trials/NCT03569644
NCT03569644
Completed
Not Applicable

Creation of a Tool to Assess Quality of Life in Patient With Auto-inflammatory Diseases

Assistance Publique - Hôpitaux de Paris3 sites in 1 country39 target enrollmentJune 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hereditary Autoinflammatory Diseases
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
39
Locations
3
Primary Endpoint
Qualitative evaluation of quality of life by interviews of patients and/or parents
Status
Completed
Last Updated
7 months ago

Overview

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).

Detailed Description

Recent understanding of the physiopathological mechanisms that underpin autoinflammatory diseases (AIDs) allowed a revolution in the therapeutic management of these patients, particularly through the use of biotherapies. However new treatments need to be evaluated by valid tools. AIDAI score created and validated by our team evaluates activity of 4 autoinflammatory diseases. One of the important components, not explored by the scores currently available, is the impact of these treatments on quality of life (QoL) of patients. The existing quality of life scales are not adapted to these recurrent chronic pathologies. Throught a qualitative study based on interviews of patients and/ or parents, the investigators aim to build a tool to evaluate QoL in patients suffering from 6 aAIDs :familial Mediterranean fever (FMF), mevalonate kinase deficiency (MKD), tumour necrosis factor receptor-associated periodic syndrome (TRAPS), cryopyrin-associated periodic syndromes (CAPS), Still's disease and PFAPA syndrome.

Registry
clinicaltrials.gov
Start Date
June 6, 2018
End Date
April 1, 2021
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 45 to 90 min

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)

Study Sites (3)

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