A Randomized Controlled Trial of Mobile Technology-assisted Outpatient Maintenance Therapy in Children With Acute Lymphoblastic Leukaemia (ALL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of time wherein white blood cell concentration is within the target range
研究概览
简要总结
To assess the efficacy of using mobile technology to improve the percentage of time wherein drug dosing is within the target range
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) < 16 years old at diagnosis;
- •2) having demonstrated ≥ 3 months of > 90% compliance with using a mobile app to log in records of daily medication and weekly blood test results;
- •3) patient or legal guardian provides informed consent
排除标准
- 未提供
研究组 & 干预措施
Intervention group
A mobile application classifies each subject's maintenance therapy dosing status as 'On Track', 'Orange Alert', or 'Red Alert' based on analysis of his/her electronic diary of medication and blood tests.
干预措施: Health monitoring & reminders for a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment. (Behavioral)
Control group
No intervention
结局指标
主要结局
Percentage of time wherein white blood cell concentration is within the target range
时间窗: After randomization
Percentage of time wherein white blood cell concentration is within the target range 2.0 - 3.0 × 10\^9/L after randomization.
次要结局
- Percentage of time wherein white blood cell concentration is < 1.0 or > 5.0 × 10^9/L(After randomization)