NCT06697262尚未招募不适用
Impact of a Telemonitoring Device on the Occurrence of Fever at Home in Children at Risk of Chemotherapy-Induced Neutropenia: A Pilot Randomized Controlled Trial
Centre Hospitalier Universitaire de la Réunion0 个研究点目标入组 30 人开始时间: 2025年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- study acceptability rate
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility of the study, measured by the acceptability rate of patients to be recruited in a study proposing temperature monitoring at home, by a remote monitoring device or by the visit of an IDE at home (in association with the usual educational sessions), to children at risk of febrile neutropenia, from families with psycho-social vulnerabilities.
The main questions it aims to answer are:
- Will participants adhere to the telemonitoring system?
- Is the intervention feasible, in terms of the device's failure to record temperature data?
- Will parents behave appropriately when using the device?
- How satisfied will parents and caregivers be?
- What will be the physical tolerance of the device?
- On an exploratory basis, will the remote monitoring system be effective for months?
Researchers will compare :
- patients using the telemonitoring device for continuous temperature monitoring at home, in combination with education sessions on temperature monitoring and the device
- with patient with temperature monitoring at home by a nurse, 2 times a day, in combination with education sessions on temperature monitoring (without the telemonitoring device at home)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 0 to 17 inclusive
- •Followed in the Pediatric Onco-Hematology Department
- •Primo-diagnosed with solid or hematological cancer (incident case)
- •Having received a first cycle of chemotherapy
- •Whose family has psycho-social vulnerabilities assessed by the Froger et al. tool, indicating a need for an IDE to support the family in monitoring the patient.
排除标准
- •with a dermatosis contraindicating the use of the device
- •Refusing to participate in the study
结局指标
主要结局
study acceptability rate
时间窗: 24 months
number of patients included/number of eligible patients offered the study.
次要结局
未报告次要终点
研究者
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