跳至主要内容
临床试验/NCT05785702
NCT05785702招募中不适用

The Effectiveness of Anti-wandering System on Early Spotting Residents in Unauthorized Areas Among People With Intellectual Disability: A Single Group Pre-post Test Study

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
The time in seconds to turn off the alarm (a proxy measure of the response time of care staff in spotting residents in unauthorized areas)

研究概览

简要总结

The study has 6 research questions regarding the use of the anti-wandering system in day activity centre cum hostel for persons with intellectual disabilities:

Primary study questions:

  1. Can the anti-wandering system reduce the time in seconds to turn off the alarm made by the system (a proxy measure of the response time of care staff)?
  2. Can the anti-wandering system reduce the burden of care staff on keeping track of the residents?

Secondary study questions: 3. How many alarms does the anti-wandering system generate? 4. How many false alarms does the anti-wandering system made as reported by staff?

Auxiliary study questions: 5. What are the reasons for keeping or loosening restrictions on users due to the use of the anti-wandering system? 6. What are the perceived benefits and feasibility of anti-wandering system compared to conventional anti-wandering practices?

详细描述

Study design

The trial is a single group pre-post test study at Haven of Hope Ming Tak Day Activity Centre and Hostel and Haven of Hope Sau Mau Ping Day Activity Centre Cum Hostel. There will be a pre-test of 4 weeks and trial of 12 weeks. During pre-test, the alarm of the anti-wandering system will be muted, and the response time in spotting participants in selected unauthorized areas without system alarm can be recorded. During the trial period, the alarm will be turned on, so that care staff will be alerted when participants enter unauthorized area.

This protocol complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki.

Procedures

  1. Participants' selection and consent

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Inclusion criteria of residents:
  • Residents of the study sites
  • Inclusion criteria of care staff:
  • Responsible for the operation of the anti-wandering system

排除标准

  • Exclusion criteria of residents:
  • Not independently mobile (i.e. unable to walk around without care staff assistance)
  • Exclusion criteria of care staff:

结局指标

主要结局

The time in seconds to turn off the alarm (a proxy measure of the response time of care staff in spotting residents in unauthorized areas)

时间窗: From the start of pre-test to the end of the 12-week trial period

The time in seconds from the alarm going off to the alarm being turned off will be recorded by anti-wandering system.

The burden of care staff on keeping track of the residents

时间窗: Before the pre-test and the end of the 12-week trial period

Care staff will complete five items indicating their burden in tracking of the participants under the anti-wandering system on a 5-point Likert scale (i.e. 1 indicating no burden and 5 indicating severe burden). The minimum and maximum values of the scale are 5 and 30 respectively, with higher score indicating care staff having burden. The contents include the perceived frequency of giving residents freedom of movement, feeling guilt in restricting residents, having conflicts with residents due to restricting them, and worrying residents to enter unauthorized areas unsupervised. At the end of the trial, they will fill in two additional questions of whether they have more time to handle other duties and whether they can better concentrate on other duties.

次要结局

  • The number of system alarms(From the start of 4-week pre-test to the end of the 12-week trial period)
  • The reasons for keeping or loosening restrictions on users due to the use of the anti-wandering system(In the mid-term review meeting during the 12-week trial period)
  • The number of false alarms reported by staff(From the start to the end of the 12-week trial period)
  • The feasibility of anti-wandering system(At the end of the 12-week trial period)
  • Qualitative measures: The perceived benefits and feasibility of anti-wandering system compared to conventional anti-wandering practices in care staff(At the end of the 12-week 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 (2)

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