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

Ramsay Générale de Santé

Status: Unknown

Conditions: Phone Use, Cell; Quality of Life; Glial Scar

Treatments: Device: Connected application arm; Device: Unconnected arm

Study type: Interventional

Funder types: Other

Identifiers

NCT05067049

2018-A03009-46

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Connected EORTC-C30 arm (quality of life questionnaires on pad, phone,...)

Experimental group

Description:

The patients in this arm will have connected mobile app at home and they will regularly fill questionnaires. There are two different questionnaires : one with 14 questions about patient's quality of life and about the evolution of his surgical scar. One with 9 questions only about quality of life. They will also have meetings with physicians.

Treatment:

Device: Connected application arm

No QoL online follow-up arm

Other group

Description:

The patient haven't any questionnaires to fill at home. This is the normal management of the pathology. They only have different meeting with the specialist,as usual.

Treatment:

Device: Unconnected arm