Embrace and Quality of Life (EMBQL)
Primary Purpose
Epilepsy, Tonic-Clonic
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Embrace with Alert and Mate apps
Embrace with Mate app only
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy, Tonic-Clonic focused on measuring epilepsy, mhealth, quality of life
Eligibility Criteria
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.
Sites / Locations
- Neurotech
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
Control group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
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:
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
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
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
will be assessed via a structured questionnaire-based interview that was Tailored for this study
Full Information
NCT ID
NCT03831802
First Posted
August 21, 2018
Last Updated
July 19, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT03831802
Brief Title
Embrace and Quality of Life
Acronym
EMBQL
Official Title
Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
because of technical issues
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
August 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Tonic-Clonic
Keywords
epilepsy, mhealth, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Embrace with Alert and Mate apps
Other Intervention Name(s)
experimental group's intervention
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Embrace with Mate app only
Other Intervention Name(s)
Control group's intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
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:
Description
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.
Time Frame
3 month
Title
Total number of true and false positives seizure detection
Description
Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app
Time Frame
3 month
Title
The usability total score of Embrace and Mate apps
Description
Will be assessed with the System usability scale (SUS). The score are to 0 from 100.
Time Frame
3 month
Title
The utility total score of the system in general
Description
will be assessed via a structured questionnaire-based interview that was Tailored for this study
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Neurotech
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Embrace and Quality of Life
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