跳至主要内容
临床试验/NCT03753035
NCT03753035Unknown不适用

Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年11月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
Mean compliance

研究概览

简要总结

There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. To obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). Propose an evaluation of the quality of life of their children by a suitable self-questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • • Child aged 5 to 17
  • Child who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data
  • Holder (s) of the parental authority present (s) having received the complete information on the organization of the research and not being opposed to the participation and the exploitation of the data of his child
  • Epileptic child
  • Follow-up at the neuro pediatric department of CHRU Nancy

排除标准

  • epileptic encephalopathy
  • Multiply handicapped child

结局指标

主要结局

Mean compliance

时间窗: 6 months

Mean compliance score measured by the validated Modified Morisky Medication Adherence Scales 8 for epileptic patients 11 subscale with a 5-point Likert scale. According to the scoring system for the MMAS, 8=high adherence, 6 to \<8=medium adherence, and \<6=low adherence. Patients who had a low or a moderate rate of adherence were considered nonadherent5.

次要结局

  • quality of life of epileptic children(6 months)
  • syndromes(6 months)
  • Compliance score of the modified Modified Morisky Medication Adherence Scales 8(6 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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