Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated

Quality of Life Clinical Trial

— TELEGLIO  

Official title:

Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated: a Prospective, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067049
• Other study ID #: 2018-A03009-46
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 2022

Study information

• Verified date: October 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. This allow to adapt their care more quickly, through a prospective randomized study. The impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female over 18 years old without upper age limit.
• Subject operated for a non-recurrent glioma (grade II or III or IV glioma / glioblastoma) according to the WHO classification 2016;
• Subject with a connected support (smartphone,...) to download the connected tracking application.
• Unprotected adult within the meaning of the law
• Subject affiliated to a health insurance scheme
• Subject having signed an informed written consent

Exclusion Criteria:

• Minor subject, pregnant or breastfeeding woman;
• Subject under a measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
• Antipsychotic treatment (neuroleptic or lithium)
• Subjects with documented cognitive disorders (Alzheimer, other dementia)
• Subject with a personal medical history of psychiatry
• Subject unable to complete a questionnaire on his own (inability to read French language , severe cognitive disorders)
• Medical contraindication to performing an MRI (pace-maker) or scanner;
• Subject refusing to sign informed consent.

Related Conditions & MeSH terms

• Gliosis
• Quality of Life

Intervention

Device:
• Connected application arm
patients have to respond different questionnaires about their quality of life on the mobile app. And follow-up visits with the physicians as usual
• Unconnected arm
Follow-up visits with the pysicians as usual

Locations

Country	Name	City	State
France	Clinique privée	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Clairval Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the impact of the connected mobile monitoring application on the quality of life, at 6 months, of patients treated for an operated glioma.	The primary outcome measure is the difference in quality of life assessed by the QLQ-BN20 scale at 6 months, compared to inclusion. This scale is made up of 20 items which are grouped into 4 dimensions (future uncertainty, visual disorder, motor dysfunction, and communication deficit) and 7 isolated items.	6 months