Use of the KASPARD System for Fall Prevention in Nursing Homes

NCT05457166 | Recruiting

• 2 other identifiers: 2020_892021-A03210-41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).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

Conditions

Nursing Homes; Accidental Falls

Keywords

Elderly person; EHPAD; Fall; Prevention; Detection system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  100 nights with the device on versus 100 nights with the device off

• Fear of falling assessed by the FES scale

  100 nights with the device on versus 100 nights with the device off

• Quality of life questionnaire

  100 nights with the device on versus 100 nights with the device off

Study Arms (1)

patients

EXPERIMENTAL

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

Interventions

KASPARD system for fall prevention in nursing homes DEVICE

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)

patients

Eligibility Criteria

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

You may qualify if:

• Male and/or female resident of an EHPAD
• Person aged ≥ 65 years
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Pôle de gérontologie - Hôpital Les Bateliers

Lille, France

RECRUITING

MeSH Terms

Interventions

Home Nursing

Intervention Hierarchy (Ancestors)

Nursing Care; Patient Care; Therapeutics; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• François Puisieux, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Puisieux, MD,PhD

CONTACT

0320445962; francois.puisieux@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: July 7, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-06

Locations

FR (1)