Quality of Life in Patients With Auto-inflammatory Diseases (MAI-PATIENT)
Primary Purpose
Hereditary Autoinflammatory Diseases
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
qualitative study
Sponsored by
About this trial
This is an interventional other trial for Hereditary Autoinflammatory Diseases
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 ...)
Sites / Locations
- CH André Mignot
- Dr Maryam PIRAM
- TENON
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
qualitative study
Arm Description
heterogeneous group of patients
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03569644
First Posted
June 15, 2018
Last Updated
July 1, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03569644
Brief Title
Quality of Life in Patients With Auto-inflammatory Diseases
Acronym
MAI-PATIENT
Official Title
Creation of a Tool to Assess Quality of Life in Patient With Auto-inflammatory Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Autoinflammatory Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
qualitative study
Arm Type
Other
Arm Description
heterogeneous group of patients
Intervention Type
Other
Intervention Name(s)
qualitative study
Intervention Description
Interviews
Primary Outcome Measure Information:
Title
Qualitative evaluation of quality of life by interviews of patients and/or parents
Description
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)
Time Frame
45 to 90 min
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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 ...)
Facility Information:
Facility Name
CH André Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Dr Maryam PIRAM
City
Le Kremlin Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
TENON
City
Paris
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Quality of Life in Patients With Auto-inflammatory Diseases
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