Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03087227
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2017-02-20
Brief Title:
Shared Health Information System for Febrile Neutropenia
Sponsor:
Marie-Helene METZGER
Organization:
University of Paris 13
Study Overview
Official Title:
Evaluation of a Shared Health Information System for Home-hospital Management of Febrile NEUTROpenia After Cytotoxic Chemotherapy
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUTROSIS
Brief Summary:
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 n100 and a cohort of patients followed by the hospitals standard care over a treatment period of six months n100 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
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 n100 and a cohort of patients followed by the hospitals standard care over a treatment period of six months n100 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None