NCT03434886已完成不适用
Evaluating Outcomes in European Cystic Fibrosis Patients With Access to Their Health Records: a Randomised Control Trial of a Registry Patient Portal
Cystic Fibrosis Registry of Ireland0 个研究点目标入组 282 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 主要终点
- FEV1pp
研究概览
简要总结
A multifactorial, parallel group, randomised control study in cystic fibrosis (CF) patients aged 13-30 years over an 18 month period. Patients will be offered read-only access to their CF registry electronic health record (CF View), or educational videos on CF (videos), or videos and CF View, or usual standard of care. The study aims are to examine the effect of patient access to C View on a range of clinical outcomes, health service usage, health literacy and patient reported outcomes.
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
- None
入排标准
- 年龄范围
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with CF
- •registered with their national CF patient registry
- •FEV1pp ≥40
- •aged 13-30 years
排除标准
- •organ transplantation
- •FEV1pp <40
研究组 & 干预措施
CF View
Experimental
干预措施: CFView (Other)
CF Educational videos
Active Comparator
干预措施: CF educational videos (Other)
CF View and videos
Active Comparator
干预措施: CFView (Other)
CF View and videos
Active Comparator
干预措施: CF educational videos (Other)
Usual standard of care
No Intervention
结局指标
主要结局
FEV1pp
时间窗: 18 months
forced expiratory volume in 1 second percentage predicted
次要结局
- BMI(18 months)
- Health literacy(12 months)
- Health-related quality of life(12 months)
- Pulmonary exacerbations(18 months)
- Hospitalisations(18 months)
研究者
Abaigeal Jackson
Research Lead
Cystic Fibrosis Registry of Ireland
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