Quality of LifeTELEGLIONCT05067049
Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated
A study testing Connected application arm and Unconnected arm in people with Quality of Life and Phone Use, Cell, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Phone Use, Cell, Glial Scar
- What is being tested?
- Connected application arm and Unconnected arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Marie-Hélène barba contact
France1 site, 1 recruiting
- Recruiting
Clinique privée
Marseille, 13009
Jean-François Oudet, jf.oudet@ecten.eu
Marie-Hélène Barba, mh.barba@ecten.eu
About this study
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
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.
- Conditions
- Quality of Life, Phone Use, Cell, Glial Scar
- Being tested
- Connected application arm, Unconnected arm
- Medical subject headings
- Cell Phone Use, Gliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected application armDevice
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 armDevice
Follow-up visits with the pysicians as usual
| Study group | Role | What they receive |
|---|---|---|
| Connected EORTC-C30 arm (quality of life questionnaires on pad, phone,...) | Experimental | 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. Receives: Device: Connected application arm |
| No QoL online follow-up arm | Other | 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. Receives: Device: Unconnected arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Feb 2019
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Clairval Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067049
- Sponsor's protocol ID
- 2018-A03009-46
- Acronym
- TELEGLIO
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05067049
- Acronym / sponsor ID
- TELEGLIO / 2018-A03009-46
- Conditions
- Quality of Life, Phone Use, Cell, Glial Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Clairval Hospital
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connected EORTC-C30 arm (quality of life questionnaires on pad, phone,...) | Experimental | Device: Connected application armThe 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. |
| No QoL online follow-up arm | Other | Device: Unconnected armThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connected application armpatients have to respond different questionnaires about their quality of life on the mobile app. And follow-up visits with the physicians as usual | Device | Connected EORTC-C30 arm (quality of life questionnaires on pad, phone,...) |
| Unconnected armFollow-up visits with the pysicians as usual | Device | No QoL online follow-up arm |
Primary outcome
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.
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected application arm and Unconnected arm in people with Quality of Life and Phone Use, Cell, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.