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临床试验/NCT02010528
NCT02010528已完成不适用

Diabetes Distress,Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With Type 1 Diabetes

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
parental diabetes-related distress

研究概览

简要总结

Parents have an important role in child's diabetes management. Many studies show that parental psychological stress and family dynamics are associated with parental diabetes-related distress and treatment outcomes among children and adolescents with type 1 diabetes.

The aim of this study is to analyze diabetes distress (diabetes-related parenting burden and fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life, positive and negative affect and adult attachment relationship pattern), family hardiness and characteristics of children with type 1 diabetes in a sample of mothers and fathers of children and adolescents with type 1 diabetes of ages up to 18 years.

In this study it is hypothesized that:

  1. greater parental fear of hypoglycemia and diabetes-related burden are associated with lower family hardiness and worse psychological well-being parents and higher HbA1c levels in children and adolescents with type 1 diabetes;
  2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower psychological well-being comparing to fathers.
  3. parents of children and adolescents with type 1diabetes will report greater anxiety, lower psychological well-being and family hardiness comparing to parents of children without diabetes.

Standardized and validated questionnaires will be used to determine: parental fear of hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being, adult attachment relationship pattern and family hardiness.

The investigators will also measure parent daily involvement in child's diabetes management, frequency of blood glucose monitoring and parent general satisfaction with glycemic control. Objective measures such as child's HbA1c level and experience of severe hypoglycemia episode will also be obtained. These measures will be correlated with other research variables.

研究设计

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

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

  • Parents or caregivers of children and adolescents with T1D of ages up to 18 years
  • Minimal 1 year duration of Type 1 diabetes

排除标准

  • Parents or caregivers of children and adolescents with T1D of ages over 18 years

结局指标

主要结局

parental diabetes-related distress

时间窗: 1 month

To examine associations between diabetes-related distress - diabetes burden (Problem Areas In Diabetes-Parent (PAID-P) questionnaire), fear of hypoglycemia (Hypoglycemia Fear Survey-Parent (HFS-P) questionnaire, Hypoglycemia Fear Survey- Parents of Young Children (HFS-PYC) questionnaire)

次要结局

  • psychosocial characteristics(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tadej Battelino

Head, Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

University Medical Centre Ljubljana

研究点 (1)

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