Childhood Diabetes - Family Based Health Interventions for Child Health
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Primary Outcome Measure: the child's metabolic control as shown in HbA1C
研究概览
简要总结
Purpose of the study:
To compare three different regimes for children newly diagnosed with type 1 diabetes: (1) traditional hospital based care, (2) intensive psychological support to the family, and (3) home based family psychosocial support. A further aim is to identify families were the child runs the risk of decreased metabolic control and to give those families increased support.
Specific objectives:
The main objectives of the study are:
- to analyse the effects on child health of family-based home care compared to traditional hospital-based care, and
- to analyse the effects on child health of family-based psychological treatment compared to traditional hospital-based treatment.
The main focus will be on child health and changes in child health. Several variables will be collected for these purpose (see instruments, below), the main variable being the child's metabolic control. We will also analyse effects on the amount and content of (1) parental efforts (absenteeism from work; time use which is conditional on the child's diabetes etc), and (2) formal health care utilisation of the home-based care and psychological treatment, respectively, compared to traditional care.
详细描述
Purpose of the study:
To compare three different regimes for children newly diagnosed with type 1 diabetes: (1) traditional hospital based care, (2) intensive psychological support to the family, and (3) home based family psychosocial support. A further aim is to identify families were the child runs the risk of decreased metabolic control and to give those families increased support.
Specific objectives:
The main objectives of the study are:
(3) to analyse the effects on child health of family-based home care compared to traditional hospital-based care, and (4) to analyse the effects on child health of family-based psychological treatment compared to traditional hospital-based treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children, aged 3 - 15
- •newly diagnosed with diabetes mellitus
- •no other chronic illnesses
- •Swedish as mother tongue
- •no siblings with type 1 diabetes
- •not objects for social interventions
排除标准
- 未提供
研究组 & 干预措施
2
effects on child health of family-based psychological treatment compared to traditional hospital-based treatment
干预措施: childhood diabetes (Behavioral)
1
effects on child health of family-based home care compared to traditional hospital-based care,
干预措施: childhood diabetes (Behavioral)
结局指标
主要结局
Primary Outcome Measure: the child's metabolic control as shown in HbA1C
时间窗: 6 months, 1 year, 2 year, 5 year
次要结局
- Quality of life, Satisfaction with care, Family impact and family climate, psychological variables, parental absenteeism from work; time use which is conditional on the child's diabetes etc), formal health care utilisation(6 months, 1 year, 2 year, 5 year)