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临床试验/NCT05391334
NCT05391334已完成不适用

Exploration and Comparison of Novel Technology-supported Methods for Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium

University Department of Geriatric Medicine FELIX PLATTER1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
Falls

研究概览

简要总结

During delirium patients are at risk of severe harm due to unattended bed-exits resulting in falls. This research intends to explore how effective alarming contact mats (CareMat®) in comparison to contactless bed-exit alarming devices (Qumea®) are to reduce the risk of unattended bed-exits and falls.

详细描述

Delirium is a neuropsychiatric disorder with a sudden and reversible decline in attention and cognition due to a medical condition.8 Delirium is associated with emotional distress for patients, their relatives and medical staff.3-5 During delirium, patients are at risk of severe harm due to unattended bed-exits and subsequent falls.6, 7 As worldwide strategy, sitters are used for the prevention of harm in patients with delirium. However, evidence of the effectiveness of sitters is scant.9 A newly designed specialised acute care unit for older patients with delirium, the FELIX PLATTER delirium unit (DelirUnit), strives to overcome the aforementioned shortcomings. On the DelirUnit there are no physical barriers such as bed rails to prevent patients from bed-exits. Floor beds minimize injuries when patients leave their beds unattended. Specialised nurses and nursing aides care for this vulnerable patient group. Sitters are banned. As an alternative to sitters, nurses are informed about patients' intended bed-exit by electronic alarming contact mats at the bedside or in front of beds (CareMat®) or by a novel contactless radar-based bed-exit monitoring system (Qumea®). Up until now, evidence for the effectiveness of technical devices for fall risk prevention is low. This research intends to explore how effective contact mats (CareMat®) or contactless bed-exit alarming devices (Qumea®) are in fall risk detection and fall prevention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •Admission at or transferal to DelirUnit. During Covid pandemic, patients will be enrolled into the study after the second negative Covid swab (PCR).

排除标准

  • •Patients who have been sectioned and must be treated in a facility, whether they agree or not (under the mental health act) (Fürsorgliche Unterbringung).
  • •No proxy consent available due to language barriers;
  • •Missing legal proxy in case of lacking family network

研究组 & 干预措施

Usual Care

Contact mat (CareMat®) for bed-exit detection in combination with Qumea fall detection.

Intervention

Contactless motion sensor (Qumea®) for bed-exit detection in combination with Qumea fall detection.

干预措施: Qumea (Device)

结局指标

主要结局

Falls

时间窗: 6 months

Number of patient falls in patient room

次要结局

  • Bed-exit patterns(6 months)
  • Nurses' workload(6 months)
  • Delirium severity(6 months)
  • Time to confirm a CareMat® / Qumea® warning by nurse presence in room(6 months)
  • Delirium duration(6 months)

研究者

发起方
University Department of Geriatric Medicine FELIX PLATTER
申办方类型
Other
责任方
Sponsor

研究点 (1)

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