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临床试验/NCT03087227
NCT03087227已完成不适用

Evaluation of a Shared Health Information System for Home-hospital Management of Febrile NEUTROpenia After Cytotoxic Chemotherapy

Marie-Helene METZGER6 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2017年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
121
试验地点
6
主要终点
average length of hospital stay for febrile neutropenia

研究概览

简要总结

The use of e-health in improving the quality of health services is a rapidly expanding research area, in particular its usefulness in patient management of the home-hospital care pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy and better identification of low-risk patients who can be treated at home could be made possible by these technologies.

The objective of this study is to evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims to compare the average length of hospital stay for febrile neutropenia among patients receiving NEUTROSIS and those receiving standard care

Materials and methods A shared information system (NEUTROSIS) has been developed to connect a smartphone web application for the patient to the existing shared medical record of the Paris Sud hospital group (AP-HP, France - 4D software).

The study consists of conducting a randomized controlled trial to compare a cohort of patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by the hospital's standard care over a treatment period of six months (n=100). During the 15 days following each chemotherapy cycle, the 2 groups of patients must take their temperature daily. Both groups are trained like any patient under chemotherapy to contact the team in case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team who will be alerted in case of fever and will contact the patient. The control group will indicate these same data in a paper diary and will have to contact the health team in case of fever as done in the usual care.

The two groups of patients will be followed 6 months through a questionnaire asked to the patient at each hospital visit for chemotherapy cycle. The questionnaire collects information on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study will take place in two hospital sites of the Paris University hospital (A Béclère and Kremlin-Bicètre).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Age> 18 years
  • Patient receiving cytotoxic chemotherapy for solid tumor or hematological malignancy
  • Patient having signed consent to participate in the study
  • Patient able to understand the protocol of care
  • Patient covered by health insurance
  • Patient with the use of a smartphone or tablet with Internet connection

排除标准

  • patient refusing to participate in the study
  • patient participating in a drug trial
  • patient receiving or shifting to a weekly chemotherapy protocol

结局指标

主要结局

average length of hospital stay for febrile neutropenia

时间窗: 6 months

average length of hospital stay for febrile neutropenia

次要结局

  • hospitalisation rate(6 months)
  • healthcare use rate(6 months)
  • Use rate(6 months)

研究者

发起方
Marie-Helene METZGER
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marie-Helene METZGER

Dr

University of Paris 13

研究点 (6)

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