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临床试验/NCT05490368
NCT05490368已完成不适用

Efficacy of Bed Mattress Sensor for Detecting Pre-fall Activities and Preventing Bedside Falls in Elderly in Residential Setting: A Quasi-experimental Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年8月16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
入组人数
26
试验地点
1
主要终点
Numbers of bedside fall incidents 6 months before and after the installation of the system and between the two groups

研究概览

简要总结

The study has 1 primary research question and 5 auxiliary research questions regarding the use of bed mattress sensor for detecting pre-fall activities in elderly residents in old-age home setting:

Primary research question:

  1. Can bedside fall incidents per 1000 bed-days be reduced comparing the 6 months before and after the installation of the bed mattress sensor system, and compared to control group?

Auxiliary research questions: 2. Can the length of fall-related hospital stay shortens comparing the 6 months before and after the installation of the system and compared to control group? 3. What are the differences in fall characteristics comparing the 6 months before and after the installation of the system and compared to control group? 4. What is the number of different types of alerts and average time to turn off the alerts of the system (proxy measure of response time of the care staff), and how are they different to bed-exit alarm system? 5. What are the immediate care delivery of the staff upon the alert of the system, and how are they different to bed-exit alarm system? 6. What are the views and comments from the operation staff, residents and/or their family members on the usage of the bed mattress sensor?

详细描述

Study design

This is a 2-group quasi-experimental trial of comparing the outcome indicators between using the bed mattress sensor system and not using any bedside fall-prevention tools except restraints in residents living in Haven of Hope Woo Ping Care & Attention Home. Residents with moderate to high fall risk in one floor will be allocated to the experimental group and use the bed mattress sensor system for 6 months. Concurrently, residents with moderate to high fall risk in the other floors who do not use bedside fall-prevention tools including bed-exit alarm system, and ultra low bed will join the study as control group. We will also assess how the workflow and manpower changes due to the use of the sensor.

Subjects

Residents of 4 different floors in Haven of Hope Woo Ping Care & Attention Home will be recruited for the main analysis.

Procedures

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Participants and group moderators cannot and will not be blinded to the intervention. Assessors of the follow-up outcomes and the research analysts will not be involved in the recruitment and intervention delivery, and will be blinded to the group allocation (single blindness).

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •of residents for main trial:
  • •Residents with fall history in the past year, or
  • •Residents with Morse Fall Scale score of 25 or higher (moderate to high fall risk)
  • •Inclusion Criteria of care staff for main trial:
  • •Operate the bed sensor system (i.e. provide related care and assistance upon the alerts of the system)
  • •Inclusion Criteria of residents for qualitative interviews:
  • •Having participated in the main trial
  • •Able to verbally communicate in Cantonese as perceived by the staff of the related home
  • •Inclusion Criteria of care staff for qualitative interviews:
  • •Having participated in the main trial
  • •Inclusion Criteria of family members for qualitative interviews:
  • •Witnessed the daily operation of the bed mattress sensor, as advised by the participating staff

排除标准

  • •of residents for main trial:
  • •Residents who are using bed-exit alarm system, ultra low beds or ripple bed (which are not suitable to use the mattress sensor)
  • •Exclusion Criteria for care staff for main trial:
  • •Exclusion Criteria of residents for qualitative interviews:
  • •Exclusion Criteria of care staff for qualitative interviews:
  • •Exclusion Criteria of family members for qualitative interviews:

研究组 & 干预措施

Bed mattress sensor system

Experimental

The experimental group uses the new bed mattress sensor system for 6 months.

干预措施: Bed mattress sensor system (Device)

Control Group

No Intervention

In the control group, participants do not use any of the following bedside fall-prevention tools: bed-exit alarm system, ultra low bed, and ripple bed during the same 6-month period.

结局指标

主要结局

Numbers of bedside fall incidents 6 months before and after the installation of the system and between the two groups

时间窗: 6 months before the 6-months trial period to the end of the 6-month trial period

The numbers of bedside fall incidents per 1000 bed-days 6 months before and after the installation of the system will be compared by retrieving data from the fall reports.

次要结局

  • The number of immediate care delivery of the staff upon the alert(From the start to the end of the 6-month trial period)
  • Qualitative measure: Fall characteristics of residents before and after the use of the system and between the two groups(6 months before the 6-months trial period to the end of the 6-month trial period)
  • The number of detector alerts made by the sensor(From the start to the end of the 6-month trial period)
  • Qualitative measure: Views and Comments from the operations residents and/or their family members on the usage of the pre-fall activity sensor(2 months after start of the 6-month trial period, and at the end of the 6-month trial period)
  • Average time in seconds to turn off the alert(every day during the 6-month trial period)
  • Qualitative measure: Views and Comments from the operations staff on the usage of the pre-fall activity sensor(2 months after the 6-month trial period, and the end of the 6-month trial period)
  • The length of hospital stay due to bedside fall incidents before and after the use of the system and between the two groups(6 months before the 6-months trial period to the end of the 6-month trial period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Derek Yee-Tak Cheung

Principal Investigator, Assistant Professor

The University of Hong Kong

研究点 (1)

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