An interventional study of Embrace with Alert and Mate apps and Embrace with Mate app only in Epilepsy, Tonic-Clonic, sponsored by Centre Hospitalier Universitaire Vaudois. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Supportive care
A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrodermal activity and accelerometry. These measures are used to automatically detect epileptic seizures that are transmitted to a mobile phone-based system for alerts and recording.
23 studies on the registry are indexed under Epilepsy, Tonic-Clonic; 3 are open to participants now.
This study's enrollment of 26 is below the median of 94 across 20 interventional studies indexed under Epilepsy, Tonic-Clonic.
Browse Epilepsy, Tonic-Clonic studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group will make use of the Alert app that sends alarms to patients mobile devices, and if desired to the mobile devices of their caregivers. This group will also use the Mate app which is used as a seizure diary
Device: Embrace with Alert and Mate apps
The control group will only use the Mate app and not the Alert app. This group will thus not receive any notification, from the device, and will be unaware, of the devices performance
Device: Embrace with Mate app only
Patients will wear the device on their wrist as often as possible during the day and night. The Embrace Watch contains sensors and memory recordings of electrodermal activity, temperature and physical activity from the wearer. This group will receive notifications on the mobile phone when seizure takes place. Quality of life questionnaires will be filled by the patients at the first follow-up and final assessments.
Also known as: experimental group's intervention
Patients will wear the device on their wrist as often as possible during the day and night. This group will just use the Mate app that summarizes Embrace Watch data for the owner and captures contextual information around events.This group will not receive any alert notification on the mobile phone when a seizure takes place.
Also known as: Control group's intervention
The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
The change between the QOLIE-31 questionnaire total score measured at the first and the final visit will serve as primary endpoint. The possible range of each scale's final score is from 0 to 100. higher scores reflect better quality of life.
Time frame: 3 month
The mean change from Baseline of the total scores of seven Quality of Life in Epilepsy Inventory-31 subscales covering the following epilepsy-specific domains:
Epilepsy-specific domains are: seizure worry, overall QOL, emotional well being, energy/fatigue subscales, medication effects, work-driving-social limits, cognitive function subscales. The possible range of each scale's final score is from 0 to 100. Higher scores reflect better quality of life.
Time frame: 3 month
Total number of true and false positives seizure detection
Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app
Time frame: 3 month
The usability total score of Embrace and Mate apps
Will be assessed with the System usability scale (SUS). The score are to 0 from 100.
Time frame: 3 month
The utility total score of the system in general
will be assessed via a structured questionnaire-based interview that was Tailored for this study
Time frame: 3 month
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Oct 2018, 0 months.
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This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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