跳至主要内容
临床试验/NCT06697262
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

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

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

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