Embrace and Quality of Life
- Conditions
- Epilepsy, Tonic-Clonic
- Interventions
- Device: Embrace with Alert and Mate appsDevice: Embrace with Mate app only
- Registration Number
- NCT03831802
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group Embrace with Alert and Mate apps 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 Control group Embrace with Mate app only 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
- Primary Outcome Measures
Name Time Method The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31 3 month 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.
- Secondary Outcome Measures
Name Time Method 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: 3 month 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.
Total number of true and false positives seizure detection 3 month Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app
The usability total score of Embrace and Mate apps 3 month Will be assessed with the System usability scale (SUS). The score are to 0 from 100.
The utility total score of the system in general 3 month will be assessed via a structured questionnaire-based interview that was Tailored for this study
Trial Locations
- Locations (1)
Neurotech
🇨🇭Lausanne, Switzerland