Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 2:23 AM
Study NCT ID:
NCT05302895
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2022-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of an All-in-one Health Monitoring Device in Elderly Residential Setting
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Efficiency of an All-in-one Health Monitoring Device in Elderly Residential Setting
Status:
COMPLETED
Status Verified Date:
2023-03
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 explores the benefits from the application of an all-in-one health monitoring device by care staff in old-age home setting: whether the average time consumed for measuring vital signs (including temperature, blood pressure and SpO2) will be shortened after the adoption of the new device. The study also assesses the satisfaction and perceived usability of the stakeholders towards the all-in-one health monitoring device.
Detailed Description:
Study design
This is a single-group experimental 10-week trial of comparing the time consumed for measuring health indicators by using the new all-in-one health monitoring device and using the traditional devices, using days as the analysis unit (i.e. comparing the time consumed in two measurements on same days). Before the trial, there will be a 2-week period of device piloting and calibration, so all residents will be measured by the new device for 12 weeks. Views and comments from the operation staff on the usage of the device will also be collected.
Subjects
Care staff and residents in Haven of Hope Woo Ping Care \& Attention Home \& Haven of Hope Nursing Home will be recruited for the main analysis. If residents are competent in giving consent, both residents and their guarantor, who are responsible for making decisions and signing documents for the residents, will be approached for consent. In cases residents are not competent in giving consents, only their guarantor will be approached for consent.
Procedures
System Installation
The system installation includes the set up of Bluetooth connection between the monitoring device and mobile device, network connection of mobile device, set up of mobile app for system dashboard monitoring, data retrieval and printing out. The service unit and the product supplier shall discuss the installation plan.
Operation protocol preparation
A protocol including the dashboard control and related operations will be prepared for the staff.
Pilot run and calibration
The service unit will invite 3-4 eligible residents to participate in the pilot run. During a routine health monitoring session, 1-2 care staff will use the new device to carry out the measurement, and document any issues that influence the operation. The operation protocol will be revised as necessary.
At the same time, the care staff would conduct artificial intelligence (AI) calibration of the all-in-one health monitoring device with the residents. AI calibration involves using a specific wristband to measure the blood pressure of every resident, so that the app of the device can learn and calibrate the measure for every resident. The time spent and problems encountered during calibration will be documented.
Staff training
A few identical training sessions will be delivered to all care staff which will cover test rationale and instructions of using the monitoring device and the dashboard. The training will be recorded for the staff to re-watch it.
Participants' selection
All residents and care staff who operate daily health monitoring on the selected floors/wards in the residential homes will be invited. Residents' height, age and other basic vital health data will be used for calibration of the all-in-one health monitoring device. No other personal information will be recorded. Before the test, the recruitment staff will introduce the study to these participants and their family caregivers.
Implementation
On each day, the care staff will carry out health monitoring (temperature, blood pressure, and SpO2) with traditional devices (i.e. thermometer and blood pressure meter) and the existing workflow protocol on the participating floor, and the data transfer with a tablet manually. Specifically, the care staff need to go out from the nursing station to visit all the residents' rooms for several rounds and carry out the measurements. After each measurement, they immediately input the data in the tablet. On top of that, they (preferably the same staff or same professional level) will go out in separate rounds and use the new monitoring device to carry out the health monitoring again on the participating floor. The staff will need to login each user's account with the smartphone application before each measurement, and log out after each measurement. Each measurement using the new device takes 30 - 60 seconds. As the data integration has been completed, so that no manual data transfer is needed. After each round of health monitoring by the new device or the traditional devices, the staff will need to fill in log sheets designed by the University of Hong Kong (HKU) to document the time consumed for the entire process. HKU will also monitor the quality of how log sheets are filled together with the investigators of Haven of Hope Christian Service (HOHCS). Towards the end of the testing period, the vital signs collected by traditional devices will be passed to HKU research team for comparing the measurements taken by traditional devices and Dyno50. To ensure anonymity, only the numeric identifiers will be included in the dataset for data analysis. The Dyno50 system will remain a closed system and the abovementioned data required for this study will be provided by the two homes upon consent of the residents and guarantors.
In the qualitative sub-study, the unit IC or his/her designated staff in each of the homes will select by convenience at least 2 residents, 2 staff who operate daily health monitoring, and 1 staff who are responsible for the supervision of the health monitoring procedure for the qualitative interview. Also, 0 - 2 caregivers will be interviewed depending on the availability of caregivers who witnessed the daily operation of the all-in-one health monitoring device, as advised by the participating staff. HKU senior research assistant will be responsible for conducting the interviews. Each semi-structured interviews will take around 30 minutes.
Blinding
Participants and group moderators cannot and will not be blinded to the intervention.
Sample size determination
The sample size is estimated by the current number of residents in the two test sites. In the Woo Ping Care \& Attention Home, 24 residents and 5 care staff will be included in this study. In the Haven of Hope Nursing Home, 40 residents and 6 care staff will be included.
Data analyses
In the main trial, paired sample t-test will be used to examine the difference in daily operation time between using the new monitoring device and the traditional devices for the 10-week main trial, adjusting for the number of residents measured. Moreover, paired sample t-test will be used to examine the difference in daily operation time between using the new monitoring device and the traditional devices for the 2-week pilot run and calibration and 10-week main trial, adjusting for the number of residents measured.
The qualitative 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 new health monitoring device. The results will then be discussed and consolidated in the panel meetings with the co-investigators.
This is a single-group experimental 10-week trial of comparing the time consumed for measuring health indicators by using the new all-in-one health monitoring device and using the traditional devices, using days as the analysis unit (i.e. comparing the time consumed in two measurements on same days). Before the trial, there will be a 2-week period of device piloting and calibration, so all residents will be measured by the new device for 12 weeks. Views and comments from the operation staff on the usage of the device will also be collected.
Subjects
Care staff and residents in Haven of Hope Woo Ping Care \& Attention Home \& Haven of Hope Nursing Home will be recruited for the main analysis. If residents are competent in giving consent, both residents and their guarantor, who are responsible for making decisions and signing documents for the residents, will be approached for consent. In cases residents are not competent in giving consents, only their guarantor will be approached for consent.
Procedures
System Installation
The system installation includes the set up of Bluetooth connection between the monitoring device and mobile device, network connection of mobile device, set up of mobile app for system dashboard monitoring, data retrieval and printing out. The service unit and the product supplier shall discuss the installation plan.
Operation protocol preparation
A protocol including the dashboard control and related operations will be prepared for the staff.
Pilot run and calibration
The service unit will invite 3-4 eligible residents to participate in the pilot run. During a routine health monitoring session, 1-2 care staff will use the new device to carry out the measurement, and document any issues that influence the operation. The operation protocol will be revised as necessary.
At the same time, the care staff would conduct artificial intelligence (AI) calibration of the all-in-one health monitoring device with the residents. AI calibration involves using a specific wristband to measure the blood pressure of every resident, so that the app of the device can learn and calibrate the measure for every resident. The time spent and problems encountered during calibration will be documented.
Staff training
A few identical training sessions will be delivered to all care staff which will cover test rationale and instructions of using the monitoring device and the dashboard. The training will be recorded for the staff to re-watch it.
Participants' selection
All residents and care staff who operate daily health monitoring on the selected floors/wards in the residential homes will be invited. Residents' height, age and other basic vital health data will be used for calibration of the all-in-one health monitoring device. No other personal information will be recorded. Before the test, the recruitment staff will introduce the study to these participants and their family caregivers.
Implementation
On each day, the care staff will carry out health monitoring (temperature, blood pressure, and SpO2) with traditional devices (i.e. thermometer and blood pressure meter) and the existing workflow protocol on the participating floor, and the data transfer with a tablet manually. Specifically, the care staff need to go out from the nursing station to visit all the residents' rooms for several rounds and carry out the measurements. After each measurement, they immediately input the data in the tablet. On top of that, they (preferably the same staff or same professional level) will go out in separate rounds and use the new monitoring device to carry out the health monitoring again on the participating floor. The staff will need to login each user's account with the smartphone application before each measurement, and log out after each measurement. Each measurement using the new device takes 30 - 60 seconds. As the data integration has been completed, so that no manual data transfer is needed. After each round of health monitoring by the new device or the traditional devices, the staff will need to fill in log sheets designed by the University of Hong Kong (HKU) to document the time consumed for the entire process. HKU will also monitor the quality of how log sheets are filled together with the investigators of Haven of Hope Christian Service (HOHCS). Towards the end of the testing period, the vital signs collected by traditional devices will be passed to HKU research team for comparing the measurements taken by traditional devices and Dyno50. To ensure anonymity, only the numeric identifiers will be included in the dataset for data analysis. The Dyno50 system will remain a closed system and the abovementioned data required for this study will be provided by the two homes upon consent of the residents and guarantors.
In the qualitative sub-study, the unit IC or his/her designated staff in each of the homes will select by convenience at least 2 residents, 2 staff who operate daily health monitoring, and 1 staff who are responsible for the supervision of the health monitoring procedure for the qualitative interview. Also, 0 - 2 caregivers will be interviewed depending on the availability of caregivers who witnessed the daily operation of the all-in-one health monitoring device, as advised by the participating staff. HKU senior research assistant will be responsible for conducting the interviews. Each semi-structured interviews will take around 30 minutes.
Blinding
Participants and group moderators cannot and will not be blinded to the intervention.
Sample size determination
The sample size is estimated by the current number of residents in the two test sites. In the Woo Ping Care \& Attention Home, 24 residents and 5 care staff will be included in this study. In the Haven of Hope Nursing Home, 40 residents and 6 care staff will be included.
Data analyses
In the main trial, paired sample t-test will be used to examine the difference in daily operation time between using the new monitoring device and the traditional devices for the 10-week main trial, adjusting for the number of residents measured. Moreover, paired sample t-test will be used to examine the difference in daily operation time between using the new monitoring device and the traditional devices for the 2-week pilot run and calibration and 10-week main trial, adjusting for the number of residents measured.
The qualitative 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 new health monitoring device. The results will then be discussed and consolidated in the panel meetings with the co-investigators.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: