Use of the KASPARD System for Fall Prevention in Nursing Homes (KASPARD)

Interest in Using the KASPARD System for the Prevention of Falls in Nursing Homes (EHPAD, for Its French Acronym)

Falls are a frequent cause of admission to nursing homes [2]. It is also the most frequently reported adverse event in these institutions.

The 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].

Home 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.

KASPARD 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 To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).

We 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

Study Overview

• Status: Completed
• Conditions: Accidental Falls; Nursing Homes
• Intervention / Treatment: Device: KASPARD system for fall prevention in nursing homes

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Pôle de gérontologie - Hôpital Les Bateliers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and/or female resident of an EHPAD
• Person aged ≥ 65 years
• Elderly person at high risk of falling (fell at least 1 time in the 6 months prior to inclusion)
• Resident or his/her legal representative who has given free, written, informed consent to participate in the trial
• Socially insured resident
• 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).

Exclusion Criteria:

• Refusal to participate in the study
• Elderly resident who has a fall and for whom the use of a restraint is deemed essential by the coordinating doctor of the EHPAD
• Persons under legal protection are not excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patients; 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

Device: KASPARD system for fall prevention in nursing homes; 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. Duration: 10 days Before period: The BEFORE period runs for 100 nights during which the device alarm is not activated, but the device records events. After 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of falls observed over a period of 100 nights with KASPARD	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.	100 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of night shift interventions		100 nights with the device on versus 100 nights with the device off
The number of nights without restraint		100 nights with the device on versus 100 nights with the device off
The time taken to intervene after a fall	Time between the occurrence of the fall and the arrival of staff at the patient's bedside	100 nights with the device on versus 100 nights with the device off
Fear of falling assessed by the FES scale	Fear of falling reported by residents at the end of each period: last day of period 1 and last day of period 2	100 nights with the device on versus 100 nights with the device off
Quality of life questionnaire	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	100 nights with the device on versus 100 nights with the device off
Resident satisfaction	Resident satisfaction will be assessed by a satisfaction questionnaire	activation period of 100 nights
Night and day staff satisfaction	Staff satisfaction will be assessed by a satisfaction questionnaire evaluating organisational aspects, disturbance of walking patients, interest in the reports provided by the system	activation period of 100 nights

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: François Puisieux, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; Fall; Elderly person; EHPAD; Detection system
• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Nursing Care; Home Care Services; Home Nursing
• Other Study ID Numbers: 2020_89; 2021-A03210-41 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No