Embrace and Quality of Life

NCT03831802 | Terminated DMC

• 1 other identifier: EMBQL
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Tonic-Clonic

Keywords

epilepsy; mhealth; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Total number of true and false positives seizure detection

  3 month

• The usability total score of Embrace and Mate apps

  3 month

• The utility total score of the system in general

  3 month

Study Arms (2)

experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Embrace with Alert and Mate apps DEVICE

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

experimental group

Embrace with Mate app only DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Neurotech

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Epilepsy, Tonic-Clonic; Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Clinical Neurosciences

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: February 6, 2019
• Study Start: October 10, 2018
• Primary Completion: October 10, 2018
• Study Completion: August 20, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)