EMBQL: Embrace and Quality of Life

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Terminated

CT.gov ID

NCT03831802

Collaborator

(none)

Enrollment

Location

Arms

34.3

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy, Tonic-Clonic	Device: Embrace with Alert and Mate apps Device: Embrace with Mate app only	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 10, 2018

Actual Primary Completion Date :

Oct 10, 2018

Actual Study Completion Date :

Aug 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group 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 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. Other Names: experimental group's intervention
Active Comparator: Control group 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. 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. Other Names: Control group's intervention

Arm

Intervention/Treatment

Experimental: experimental group

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

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.

Other Names:

experimental group's intervention

Active Comparator: Control group

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. 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.

Other Names:

Control group's intervention

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurotech	Lausanne		Switzerland	1011

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philippe Ryvlin, Head of Department of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT03831802

Other Study ID Numbers:

EMBQL

First Posted:

Feb 6, 2019

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Philippe Ryvlin, Head of Department of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois

epilepsy

mhealth

quality of life

Additional relevant MeSH terms:

Epilepsy

Epilepsy, Tonic-Clonic

Epilepsy, Generalized

Study Results

No Results Posted as of Jul 22, 2022