Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT05457166
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2022-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the KASPARD System for Fall Prevention in Nursing Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006701', 'term': 'Home Nursing'}], 'ancestors': [{'id': 'D009732', 'term': 'Nursing Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006699', 'term': 'Home Care Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2022-07-08', 'studyFirstSubmitQcDate': '2022-07-08', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of falls observed over a period of 100 nights with KASPARD', 'timeFrame': '100 nights', 'description': 'To show that the KASPARD system reduces the number of falls observed over a period of 100 nights with the device activated compared to a period of 100 nights with the device deactivated, in elderly people aged over 65 years residing in EPAD and at high risk of falling.'}], 'secondaryOutcomes': [{'measure': 'The number of night shift interventions', 'timeFrame': '100 nights with the device on versus 100 nights with the device off'}, {'measure': 'The number of nights without restraint', 'timeFrame': '100 nights with the device on versus 100 nights with the device off'}, {'measure': 'The time taken to intervene after a fall', 'timeFrame': '100 nights with the device on versus 100 nights with the device off', 'description': "Time between the occurrence of the fall and the arrival of staff at the patient's bedside"}, {'measure': 'Fear of falling assessed by the FES scale', 'timeFrame': '100 nights with the device on versus 100 nights with the device off', 'description': 'Fear of falling reported by residents at the end of each period: last day of period 1 and last day of period 2'}, {'measure': 'Quality of life questionnaire', 'timeFrame': '100 nights with the device on versus 100 nights with the device off', 'description': 'Quality of life questionnaire reported by the patient and once at the end of each period: last day of period 1 and last day of period 2'}, {'measure': 'Resident satisfaction', 'timeFrame': 'activation period of 100 nights', 'description': 'Resident satisfaction will be assessed by a satisfaction questionnaire'}, {'measure': 'Night and day staff satisfaction', 'timeFrame': 'activation period of 100 nights', 'description': 'Staff satisfaction will be assessed by a satisfaction questionnaire evaluating organisational aspects, disturbance of walking patients, interest in the reports provided by the system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly person', 'EHPAD', 'Fall', 'Prevention', 'Detection system'], 'conditions': ['Accidental Falls', 'Nursing Homes']}, 'descriptionModule': {'briefSummary': "Falls are a frequent cause of admission to nursing homes \\[2\\]. It is also the most frequently reported adverse event in these institutions.\n\nThe prevention of falls in EHPAD must mobilise several levers of action and involve all staff. It must be included in the establishment's project in the same way as the policy on the proper use of restraints \\[21\\].\n\nHome automation and new technologies can contribute to the prevention of falls and their consequences. Most of the existing solutions on the market are either fall detection solutions based on a watch or pendant or rise detection solutions based on a sub-mattress or floor mat. All of these solutions work with a contact and often require a daily set-up or check by the care teams. But the real challenge today for new technologies is to prevent falls in the elderly, by directly addressing the risk factors.\n\nKASPARD is a non-contact (remote sensors) and non-intrusive (no video image, it uses point cloud technology) solution for detecting falls, excessive wandering and nocturnal activities in a nursing home. The information is transmitted securely via the wifi network to a mobile phone (or TSI/DECT) and to a computer. The KASPARD solution, which is already on the market (non-medical CE marking), is used in several EHPADs in Belgium and France. It is not a medical device. To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).\n\nWe wish to verify the effectiveness of the KASPARD technology for the prevention of falls in EHPAD, suggested for the moment by an observational study, with the help of a multi-centre clinical study"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and/or female resident of an EHPAD\n* Person aged ≥ 65 years\n* Elderly person at high risk of falling (fell at least 1 time in the 6 months prior to inclusion)\n* Resident or his/her legal representative who has given free, written, informed consent to participate in the trial\n* Socially insured resident\n* Resident willing to comply with all study procedures and duration. The questionnaires used will be validated questionnaires for the target population (QoL-AD questionnaire for residents and their carers).\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Elderly resident who has a fall and for whom the use of a restraint is deemed essential by the coordinating doctor of the EHPAD\n* Persons under legal protection are not excluded.'}, 'identificationModule': {'nctId': 'NCT05457166', 'acronym': 'KASPARD', 'briefTitle': 'Use of the KASPARD System for Fall Prevention in Nursing Homes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Interest in Using the KASPARD System for the Prevention of Falls in Nursing Homes (EHPAD, for Its French Acronym)', 'orgStudyIdInfo': {'id': '2020_89'}, 'secondaryIdInfos': [{'id': '2021-A03210-41', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients', 'description': 'patients in a before/after experimental design to assess the value of using the KASPARD technology compared to the conventional management of patients with falls in nursing homes', 'interventionNames': ['Device: KASPARD system for fall prevention in nursing homes']}], 'interventions': [{'name': 'KASPARD system for fall prevention in nursing homes', 'type': 'DEVICE', 'description': 'All subjects will be monitored for 2 periods of 100 nights each. Recordings will be made continuously at night for the duration of the study Period 0: set-up, adjustment, recording (without alarm); This is a preparatory phase which is part of the usual use of the device.\n\nDuration: 10 days Before period: The BEFORE period runs for 100 nights during which the device alarm is not activated, but the device records events.\n\nAfter period: The AFTER period is 100 nights during which the device alarm is activated: Monitoring with recording + alarm activated (usual care + action if alarm is triggered)', 'armGroupLabels': ['patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'François Puisieux, MD,PhD', 'role': 'CONTACT', 'email': 'francois.puisieux@chru-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'François Puisieux, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}