Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837585
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-03-16
Brief Title:
The Effectiveness of Air Quality Sensor in Elderly Residential Setting
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg opening windows switching on fresh air supply fans and air purifiers etc and long-term measures eg 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 units 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 softwares will be installed in computers in the nurse stations The service units 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 ie 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 eg moving the materials that are suspected to worsen air quality report to the managers of service units 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 units will decide the changes of activities to improve air quality eg opening windows switching on fresh air supply fans and air purifiers etc and long-term measures eg 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 units 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
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 eg opening windows switching on fresh air supply fans and air purifiers etc and long-term measures eg 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 units 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 softwares will be installed in computers in the nurse stations The service units 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 ie 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 eg moving the materials that are suspected to worsen air quality report to the managers of service units 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 units will decide the changes of activities to improve air quality eg opening windows switching on fresh air supply fans and air purifiers etc and long-term measures eg 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 units 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None