跳至主要内容
临床试验/NCT06133426
NCT06133426招募中不适用

Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Percentage of patients who agreed to participate in research

研究概览

简要总结

In this research, we will evaluate the feasibility of following by remote monitoring, using a connected scale, in hematology patients suffering from myeloma or lymphoma and requiring treatment with chemotherapy. 30 patients will be included in the research and will all use a connected scale for the duration of their participation (7 weeks +/- 1 week). During their participation, patients will be asked to weigh themselves once a day, ideally at a set time. Patient data will be accessible by the medical team via a remote monitoring platform.

Alerts will be generated in the event of abnormal development of certain clinical parameters (weight, heart rate, etc.) allowing early treatment to be implemented by the medical team.

At the end of their participation, we will evaluate patients' support and perception of this tool, as well as the healthcare consequences of the alerts generated by the remote monitoring platform.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 and over (male or female)
  • Patient suffering from aggressive non-Hodgkin's lymphoma or multiple myeloma with a plan for systemic chemotherapy or having started two cycles or less or patient with the need for therapeutic intensification under the cover of autograft in the context of myeloma or lymphoma
  • Patient who can be contacted by telephone during their participation in the research
  • Patient able to return home at the end of their initial hospitalization
  • Patient affiliated to social security
  • Patient able to read and speak French
  • Patient having signed free, informed and written consent

排除标准

  • Patient with an estimated life expectancy < 3 months
  • Patient with moderate to severe cognitive impairment (assessed by MMSE < 20)
  • Patient with a psychiatric or physical disability that does not allow the use of the device
  • Patient with a pacemaker
  • Patient participating in another intervention research project
  • Pregnant patient
  • Patient deprived of liberty
  • Patient under legal protection (guardianship or curatorship)

结局指标

主要结局

Percentage of patients who agreed to participate in research

时间窗: Inclusion

Number of included patients / Number of indormed patients

次要结局

  • Evaluation of the ease of use of the device perceived by the patient(week 7)
  • Assessment of the patient's anxiety regarding the device(week 7)
  • Evaluation of the implementation of the study by the patient(week 7)
  • Frequency of use of the connected scale during the patient's participation in the research(From inclusion to week 7)
  • Evaluation of the consequences in care of alerts generated by the plateform(From inclusion to week 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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