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临床试验/NCT04793854
NCT04793854已完成不适用

Sickle Cell Disease, Neurocognitive Disorders, Social Participation

Centre Hospitalier Universitaire de Pointe-a-Pitre1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2018年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
134
试验地点
1
主要终点
MQE

研究概览

简要总结

This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders.

详细描述

Sickle cell anaemia, which is the most frequent genetic disease in France, requires an early and optimal care to reduce its morbidity and mortality. Children with sickle cell anaemia who are significantly anaemic may present neurological complications including stroke with or without clinical signs. A major risk associated to these strokes is the impairment of the general intellectual ability and learning ability, essentially resulting from neuropsychological disorders affecting intellectual functioning, executive and attentional functions. Although the negative impact of sickle cell anemia on the quality of life of the affected children and adolescents is well documented, no study has been focused on the role played by the neurocognitive disorders on their social participation. The objective of this project is the assessment of the influence of neurocognitive disorders in the social participation of children and adolescent with sickle cell anemia (6 to 16 years old), followed in Guadeloupe. This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Sickle cell anemia
  • Age between 6 and 16 years inccuded, attending the centre of reference for sickle cell disease in Guadeloupe
  • Informed consent
  • Medical insurance

排除标准

  • Other sickle cell syndrome other than SS or Sb-thal
  • Less than 6 years old or older than 16
  • Attending other sickle cell departments
  • No medical insurance

结局指标

主要结局

MQE

时间窗: Inclusion

Measure of Environmental Quality (MQE)

MHAVIE-Children

时间窗: Inclusion

Assessment of Life Habits-LIFE-H

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Pointe-a-Pitre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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