Embrace and Quality of Life

Study Overview
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Brief Summary
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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.

Official Title
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Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study

Conditions
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Epilepsy, Tonic-Clonic

Intervention / Treatment
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* Device: Embrace with Alert and Mate apps
* Device: Embrace with Mate app only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female aged >18 years old clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion seizure frequency > 1 seizure/month during the last three months signed the informed consent form own a mobile phone device compatible with the embrace apps able to use the device without help from caregivers Exclusion Criteria: patients aged less than 18 years old epilepsy diagnosis remains uncertain evidence of psychogenic non epileptic seizures seizure frequency below 1/month during any of the three previous months past-history of nickel allergy and contact dermatitis did not sign the informed consent form does not own mobile phone device compatible with the embrace apps cognitive or behavioral impairment preventing compliance or correct use of the device and app.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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<br>* 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.<br>* Other names: experimental group's intervention;|
| Active Comparator: Control group<br>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<br>* 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.<br>* Other names: Control group's intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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 | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, mhealth, quality of life