Epilepsy, Tonic-Clonic
Conditions
Keywords
epilepsy, mhealth, quality of life
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.
Interventions
DEVICEEmbrace with Alert and Mate apps
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.
DEVICEEmbrace with Mate app only
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.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed