Creation of a Tool to Assess Quality of Life in Patient With Auto-inflammatory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Qualitative evaluation of quality of life by interviews of patients and/or parents
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •patient or relative (according to age)refuse to participate.
- •Bad understanding of French.
- •Other chronic inflammatory pathology associated (example: Crohn's, SPA, uveitis, psoriasis ...)
研究组 & 干预措施
qualitative study
heterogeneous group of patients
干预措施: qualitative study (Other)
结局指标
主要结局
Qualitative evaluation of quality of life by interviews of patients and/or parents
时间窗: 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)
次要结局
未报告次要终点