Clinical trial NCT05837585: The Effectiveness of Air Quality Sensor in Elderly Residential Setting
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Technology
Signs and Symptoms, Respiratory
Keywords: Gerontechnology
Air quality sensor
Air quality improvement
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Haven of Hope Hospital
name: The Social Innovation and Entrepreneurship Development Fund, Hong Kong
First posted: 2023-05-01
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The air quality sensors will install at the designated places and only serve to provide air quality indexes for the study site to improve air quality. The sensors will detect air quality at 2 weeks during the pre-test period and the alarm threshold will be set base on the 2-week data. During the 12 weeks trial period, based on the analysis on past 2-week air quality indexes, the managers of service unit will decide the changes of activities to improve air quality and long-term measures. The respiratory symptoms, blood pressure, pulse rate of participants will be collected during the pre-test and trial period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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?

Detailed description: 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

   The supplier will first visit the service unit(s) to determine the areas that probably have the worst air quality (usually these places are where many people gather yet lack ventilation). After confirming with the service unit managers, the sensors will be installed at the designated places. Related software(s) will be installed in computers in the nurse stations. The service unit(s) and the product supplier shall discuss the installation plan.
2. Participants' selection and consent

   The care staff will screen the appropriate residents with the eligibility criteria. The care staff will notify the eligible residents face-to-face individually about the air quality sensor and study. Their next of kin will be informed of the new devices and the study through standard channel of the test site (i.e. messaging mobile phone app or phone). If they do not want the residents to participate, they can notify the care staff. Unless they indicate withdrawal from the study, they are treated as consenting the residents to join the study (opt-out participation). The participants and their next of kins could request removal of the sensors and withdraw from the study at any time.

   Opt-out is considered sufficient to protect the rights of the vulnerable subjects. The air quality sensors only serve to provide additional information for the study site to improve care delivery. All measures taken to improve the air quality are determined by the study sites and not by the research. The participants and their next of kin can express their objections to the measures directly to the staff. The comments handling procedures adopted in daily care will be followed, such that when the study site sees it the best interest of the residents, the measures will be modified or terminated. The sensors will be installed in locations out of touch by the residents. They are light grey in colour and will not capture their attention.

   Before qualitative interviews with the participants and the staff, written consent will be obtained from them.
3. Pre-test

   The service unit will use the sensors to detect air quality for the first 2 weeks. The data will be reviewed to see if the readings are plausible. At the end of the pre-test, the staff will record the frequency of respiratory symptoms, including coughing, having sputum, having shortness of breath, and having runny nose, of the participants. Blood pressure and pulse rate are collected as a care routine of the test site and retrieved as secondary data. The research team, the supplier and the manager of the test site will analyze and review the air quality during the pre-test. An alarm threshold will be set for the 12-week trial period.
4. Implementation and data collection

During the pre-test and 12-week trial period, if the alert thresholds are set, when the air quality index is worse than the threshold, an alert will go off, and the staff will try to find out and document the possible reasons for worsened air quality. The care staff will take appropriate actions to improve air quality (e.g. moving the materials that are suspected to worsen air quality, report to the managers of service unit(s)). For the participants with respiratory and pulmonary illnesses, at the end of week 2, week 4, week 6, week 8, week 10 and week 12, the staff will record their respiratory symptoms. For other participants, their respiratory symptoms will be recorded at the end of week 2, week 4, week 8 and week 12. The University of Hong Kong (HKU) will assist analyzing the air quality of past 2 weeks retrieved from the air quality sensor. Based on the analysis, with the aim of improving air quality, the managers of the service unit(s) 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, etc.) in the next 2 weeks. These changes, including the rationales for change and non-change in the measures, will be documented in decision records.

The number of sick days and hospital days of the residents in the previous 12 weeks will be retrieved at the end of the pre-test and 12-week trial.

At the end of the trial, qualitative interviews will be conducted to assess the perceived benefits and feasibility of the air quality sensor. A total of 2 to 3 residents and 2 to 5 staff will be interviewed.

Blinding

No blinding will be done for this single group study.

Sample size determination

The sample size is estimated by the number of air quality sensors and the number of residents staying in rooms with these sensors installed. It is expected that 60 elderly persons will join the study, and 2 - 5 care staff will be interviewed.

Data analyses

1. Main analysis

   Linear mixed modeling will be used to examine the changes in respiratory symptoms, pulse rate, systolic blood pressure, diastolic blood pressure, and the air quality indexes. Independent sample t-test will be used to test the difference of the number of sick days and hospital days of participants between pre-test and 12-week trial period.
2. Process evaluations

   The activities of air quality improvement and long-term measures decided by the managers of the service unit(s) will be summarized.
3. Qualitative interview

The interview content will be transcribed verbatim in Chinese for further analysis. The qualitative interview transcripts will be analyzed using framework analysis to construct a coherent and logical structure from the classification of many opinions and perceptions of the smart environment monitoring system. The results will then be discussed and consolidated in the panel meetings with the co-authors.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria of residents and care staff:

* None

Primary outcomes:
measure: Change from Baseline respiratory symptoms every two weeks until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
Secondary outcomes:
measure: Change from Baseline pulse rate every week until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: Change from Baseline blood pressure every week until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: Qualitative measures: Change of air quality improvement measures every two weeks until week 14
timeFrame: From the end of 2-week pre-test to the end of 12-week trial period
measure: The changes in temperature until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: The changes in humidity until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: The changes in carbon dioxide until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: The changes in respirable suspended particulates (PM2.5) until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: The changes in total volatile organic compounds (TVOC) until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: The changes in formaldehyde until week 14
timeFrame: From the start of 2-week pre-test to the end of 12-week trial period
measure: The changes in the number of sick days of participants between 12 weeks before the trial and trial period
timeFrame: From 12 weeks before the trial to the end of 12-week trial period
measure: The number of hospital days of participants between 12 weeks before the trial and trial period
timeFrame: From 12 weeks before the trial to the end of 12-week trial period
measure: Qualitative measures: The perceived benefits and feasibility of the air quality sensor of residents
timeFrame: At the end of 12-week trial period
measure: Qualitative measures: The perceived benefits and feasibility of the air quality sensor of care staff
timeFrame: At the end of 12-week trial period
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Woo Ping Care & Attention Home
Study officials:
affiliation: The University of Hong Kong
name: Yee Tak Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: