Quality of Life and Psychosocial Dimensions in Children With Congenital or Acquired Hypopituitarism
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Quality of life measurement
研究概览
简要总结
Relatively little is known about the quality of life (QOL) of patients with hypopituitarism, particularly children. Quality of life studies have mostly focused on improvements following the initiation of growth hormone treatment in adults with growth hormone deficiency. Overall QOL data on patients with multiple pituitary hormone deficiency or another isolated deficiency are much scarcer. These studies suggest however that pituitary deficiencies affect the QOL and social integration of adults. In children, the psychosocial repercussions of the disease are very poorly understood, particularly in the case of multiple congenital pituitary hormone deficiency.
详细描述
Objectives:
- Describe the quality of life and psychosocial repercussions of the disease in children 10-17 years of age with multiple pituitary hormone deficiency (either acquired or congenital), or isolated pituitary hormone deficiency (other than idiopathic isolated growth hormone deficiency).
- Compare the QOL and psychosocial indicators of these patients with those of the general population
- Study the effects of various factors (medical, social, psychological) on patient outcomes and experiences of the disease.
Methods
- Prospective analytical pilot study involving the four hospitals in the Referral Centre for Rare Pituitary Diseases (Centre de Référence des Maladies Rares de l'Hypophyse, HYPO)
- Questionnaire data will be collected among patients and their parents during follow-up consultations.
- Children's quality of life will be evaluated using the Kidscreen-10 questionnaire (for children and parents) and PedsQL multidimensional fatigue scale. Psychosocial indicators (standard of living, schooling, recreation activities, social and family relationships, perceived health status and physical appearance) will be gathered using a questionnaire based on the HBSC (Health Behaviour in School-Aged Children) questionnaire (INPES 2010), and compared with data from the general population of elementary-, middle-and high-school children in France.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10-17 years
- •Multiple or isolated pituitary hormone deficiency
- •Deficiency diagnosed for a least 6 months
排除标准
- •Isolated growth hormone deficiency with normal MRI findings and/or no previous irradiation of the hypothalamo-pituitary region and/or no known genetic cause.
- •Secondary pituitary deficiency due to a secreting adenoma
- •Inability to complete the questionnaire (intellectual disability, low French language proficiency)
- •No health coverage
结局指标
主要结局
Quality of life measurement
时间窗: 1 day
The KIDSCREEN-10 score consists of 10 items and provides a Rasch-scaled single score of HRQoL. Both self-report and proxy versions will be used.
次要结局
- Fatigue(1 day)
- Psychosocial parameters(1 day)
- Socioeconomic status(1 day)