Effectiveness of the Paediatric Electronic Quality of Life Instrument for Childhood Asthma in the Netherlands (Pelican) in Medical Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- quality of life
研究概览
简要总结
The objective of this project is to establish the effectiveness of implementation of a self-administered electronic asthma-specific quality of life instrument for childhood asthma in primary care and specialist care.
详细描述
Health related quality of life (HRQL) is important to the asthmatic child and if HRQL aspects are taken into account in daily care this could result in improved treatment satisfaction, compliance, asthma control and, ultimately, improved HRQL. The Pelican instrument we have developed has the essential features to be useful in daily care. In this study, the effectiveness of implementing the Pelican instrument in medical care is assessed. An intervention study with 9 months follow-up in primary and secondary care will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6 to 12 years
- •physician-diagnosed asthma
- •use of bronchodilators and / or inhaled corticosteroids for at least six weeks during the previous year
- •child is treated for its asthma by the recruiting physician
- •signed informed consent by parent (or caretaker)
- •child agrees to participate in the study
排除标准
- •comorbid condition that significantly influences HRQL
- •child does not master the Dutch language sufficiently
- •not being able to attend a regular school class
研究组 & 干预措施
usual primary care
Number of participating children: 85
PELICAN Primary care
Intervention arm: the integration of the output of the Pelican instrument (i.e., individualised HRQL information) in daily care to guide disease management for children with asthma treated in primary care. Number of participants: 85 children
干预措施: PELICAN Primary Care (Other)
usual secondary care
number of participating children: 50
PELICAN Secondary Care
Intervention arm: the integration of the output of the Pelican instrument (i.e., individualised HRQL information) in daily care to guide disease management for children with asthma treated in primary care. Number of participants: 50 children
干预措施: PELICAN Secondary Care (Other)
结局指标
主要结局
quality of life
时间窗: 9 months
Asthma specific health related quality of life measured with the Pediatric asthma quality of life questionnaire PAQLQ(S)
次要结局
- Symptoms and medication(9 months)
- asthma control(9 months)
- caregiver quality of life(9 months)
- Lung function(9 months)
- Cost-effectiveness(9 months)
- process-outcomes(9 months)
研究者
T. Schermer
PhD
Radboud University Medical Center