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临床试验/NCT05837585
NCT05837585招募中不适用

The Effectiveness of Air Quality Sensor on Resident Wellbeing and Changes in Care Routines in Elderly Residential Setting: A Single Group Pre-post Test Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Change from Baseline respiratory symptoms every two weeks until week 14

研究概览

简要总结

The study has 7 research questions regarding the use of the air quality sensor in residential care home for the elderly:

Primary study questions:

  1. Can the real-time monitoring of air quality and the subsequent activities to improve air quality and long-term measures reduce respiratory symptoms?

Secondary study questions: 2. Can the real-time monitoring of air quality and the subsequent activities to improve air quality and long-term measures reduce pulse rate, systolic blood pressure and diastolic blood pressure? 3. What are the activities to improve air quality and long-term measures that aim to improve air quality, including the rationales for change and non-change of the measures? 4. What are the changes in air quality indexes recorded by the air quality sensor?

Auxiliary study questions: 5. How many days do the residents feel sick and stay in hospitals? 6. What are the perceived benefits and feasibility of the air quality sensor?

详细描述

Study design

The trial is a single group pre-post test study at Haven of Hope Woo Ping Care and Attention Home. There will be a pre-test of 2 weeks and trial of 12 weeks. During pre-test, the service unit will use the sensors to detect air quality. During the trial period, based on the analysis on air quality indexes in the past 2 weeks, the managers of the service unit will decide the changes of activities to improve air quality (e.g. opening windows, switching on fresh air supply fans and air purifiers, etc.) and long-term measures (e.g. using materials or plants that improve air quality, rearrange the bedroom, reschedule use of the rooms and activity schedule, replace air purifiers filters regularly, etc.) that may improve air quality.

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. System installation

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
否

入选标准

  • •Inclusion criteria of residents:
  • •Reside on the floor of the study site that will be installed with the air quality sensors, and
  • •Preferably have respiratory and pulmonary illnesses
  • •Inclusion criteria of care staff:
  • •Responsible for the general care of the participants

排除标准

  • •Exclusion criteria of residents and care staff:

研究组 & 干预措施

Air quality sensors

Experimental

The experimental group will use the air quality sensors during 2 weeks pre-test and 12 weeks trial period.

干预措施: Air quality sensors (Device)

结局指标

主要结局

Change from Baseline respiratory symptoms every two weeks until week 14

时间窗: From the start of 2-week pre-test to the end of 12-week trial period

Change of four respiratory symptoms of participants, including coughing, having sputum, having shortness of breath and having runny nose, will be observed and recorded by the care staff every two weeks. Care staff will complete four items on a 5-point Likert scale (i.e. 1 indicating no symptoms and 5 indicating serve symptoms). The minimum and maximum values of the scale is 5 and 25 respectively, with higher score indicating more severe respiratory symptoms.

次要结局

  • The changes in respirable suspended particulates (PM2.5) until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • Change from Baseline blood pressure every week until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • Qualitative measures: The perceived benefits and feasibility of the air quality sensor of residents(At the end of 12-week trial period)
  • Change from Baseline pulse rate every week until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • The changes in temperature until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • The changes in carbon dioxide until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • The changes in the number of sick days of participants between 12 weeks before the trial and trial period(From 12 weeks before the trial to the end of 12-week trial period)
  • Qualitative measures: Change of air quality improvement measures every two weeks until week 14(From the end of 2-week pre-test to the end of 12-week trial period)
  • Qualitative measures: The perceived benefits and feasibility of the air quality sensor of care staff(At the end of 12-week trial period)
  • The changes in humidity until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • The changes in total volatile organic compounds (TVOC) until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • The changes in formaldehyde until week 14(From the start of 2-week pre-test to the end of 12-week trial period)
  • The number of hospital days of participants between 12 weeks before the trial and trial period(From 12 weeks before the trial to the end of 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 (1)

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