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临床试验/NCT03529188
NCT03529188已完成不适用

Validation of the French Version of the Three Scales for Assessing the Fear of Type 1 Hypoglycemia (HFS-C, HFS-PYC and HFS-P) in Children, Adolescents and Their Parents by a Monocentric Transverse Psychometric Study

University Hospital, Brest6 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2018年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
194
试验地点
6
主要终点
HFS-Child score,

研究概览

简要总结

Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. It would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal.

If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years of age, on the other hand, there are no French and no French studies have evaluated the prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes.

It is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. Having a tool in French and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) In order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia

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
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 2 and 18 years
  • Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody
  • insulin-treated type 2 diabetes by daily injections or insulin pump

排除标准

  • Trouble to read
  • Trouble to understand
  • Trouble to answer to the questionnaire
  • Opposition.

结局指标

主要结局

HFS-Child score,

时间窗: Month 0

Change of Behaviour adopted by the patient in order to avoid the occurrence of hypoglycemia and worry about low blood sugar

HFS-PYC score

时间窗: Month 0, Month 3 (+/- 30 days)

Change in Anxiety related to the phenomenon of hypoglycemia

HFS-Parent score

时间窗: Month 0, Month 3 (+/- 30 days)

Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia

次要结局

  • Questionnaire Survey "parents "(Month 0, Month 3 (+/- 30 days))
  • Questionnaire Survey "children "(Month 0, Month 3 (+/- 30 days))
  • HbA1C(Month 0, Month 3 (+/- 30 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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