Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-08 @ 11:21 PM
Study NCT ID:
NCT03831802
Status:
TERMINATED
Last Update Posted:
2022-07-22
First Post:
2018-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embrace and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004830', 'term': 'Epilepsy, Tonic-Clonic'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'because of technical issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31', 'timeFrame': '3 month', '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."}], 'secondaryOutcomes': [{'measure': '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:', 'timeFrame': '3 month', '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."}, {'measure': 'Total number of true and false positives seizure detection', 'timeFrame': '3 month', 'description': 'Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app'}, {'measure': 'The usability total score of Embrace and Mate apps', 'timeFrame': '3 month', 'description': 'Will be assessed with the System usability scale (SUS). The score are to 0 from 100.'}, {'measure': 'The utility total score of the system in general', 'timeFrame': '3 month', 'description': 'will be assessed via a structured questionnaire-based interview that was Tailored for this study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epilepsy', 'mhealth', 'quality of life'], 'conditions': ['Epilepsy, Tonic-Clonic']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female aged \\>18 years old\n* clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure\n* primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion\n* seizure frequency \\> 1 seizure/month during the last three months\n* signed the informed consent form\n* own a mobile phone device compatible with the embrace apps\n* able to use the device without help from caregivers\n\nExclusion Criteria:\n\n* patients aged less than 18 years old\n* epilepsy diagnosis remains uncertain\n* evidence of psychogenic non epileptic seizures\n* seizure frequency below 1/month during any of the three previous months\n* past-history of nickel allergy and contact dermatitis\n* did not sign the informed consent form\n* does not own mobile phone device compatible with the embrace apps\n* cognitive or behavioral impairment preventing compliance or correct use of the device and app.'}, 'identificationModule': {'nctId': 'NCT03831802', 'acronym': 'EMBQL', 'briefTitle': 'Embrace and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study', 'orgStudyIdInfo': {'id': 'EMBQL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', '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', 'interventionNames': ['Device: Embrace with Alert and Mate apps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', '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', 'interventionNames': ['Device: Embrace with Mate app only']}], 'interventions': [{'name': 'Embrace with Alert and Mate apps', 'type': 'DEVICE', 'otherNames': ["experimental group's 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.', 'armGroupLabels': ['experimental group']}, {'name': 'Embrace with Mate app only', 'type': 'DEVICE', 'otherNames': ["Control group's 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.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Neurotech', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Clinical Neurosciences', 'investigatorFullName': 'Philippe Ryvlin', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}