Quality of Life in Patients With Auto-inflammatory Diseases

Hereditary Autoinflammatory Diseases Clinical Trial

— MAI-PATIENT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03569644
• Other study ID #: K160903J
• Secondary ID: 2017-A02673-50
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 ...)

Related Conditions & MeSH terms

• Familial Mediterranean Fever
• Hereditary Autoinflammatory Diseases

Intervention

Other:
• qualitative study
Interviews

Locations

Country	Name	City	State
France	CH André Mignot	Le Chesnay
France	Dr Maryam PIRAM	Le Kremlin Bicêtre
France	TENON	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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