Interest in Using the KASPARD System for the Prevention of Falls in Nursing Homes (EHPAD, for Its French Acronym)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- the number of falls observed over a period of 100 nights with KASPARD
研究概览
简要总结
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 To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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
干预措施: KASPARD system for fall prevention in nursing homes (Device)
结局指标
主要结局
the number of falls observed over a period of 100 nights with KASPARD
时间窗: 100 nights
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.
次要结局
- 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)
- Night and day staff satisfaction(activation period of 100 nights)
- 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)
- Resident satisfaction(activation period of 100 nights)