TechnologyNCT05302895
Efficiency of an All-in-one Health Monitoring Device in Elderly Residential Setting
An observational study of Technology, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Technology
- What is being tested?
- All-in-one health monitoring device
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 2 sitesHong Kong
- Study dates
- 12 May 2022to 1 Sep 2022
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study populations are residents in Haven of Hope Woo Ping Care \& Attention Home, residents in Haven of Hope Nursing Home, and nurses, health workers, and/or family members of the residents
Who may be able to join
- are responsible for the supervision of the health monitoring procedure and those who are responsible for the operation of daily health monitoring
- are able to hold the all-in-one health monitoring device with his/her thumbs and index fingers of both hands under the assistance of the staff
- Inclusion Criteria of care staff for qualitative interviews:
- Having participated in the main trial
- Having participated in the main trial
- Able to verbally communicate in Cantonese as perceived by the staff of the related home
- Inclusion Criteria of family members for qualitative interviews:
- Having witnessed the daily operation of the all-in-one health monitoring device
Who cannot join
- None
- Residents with implanted pacemakers and/or implanted cardio-defibrillators (ICDs)
- Exclusion Criteria of care staff for qualitative interviews:
- None
- None
- Exclusion Criteria of family members for qualitative interviews:
- None
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Haven of Hope Nursing Home
Hong Kong
Haven of Hope Woo Ping Care & Attention Home
Hong Kong
About this study
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.
Read the 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.
- Conditions
- Technology
- Being tested
- All-in-one health monitoring device
- Keywords
- Gerontechnology, Smart Healthcare Device, Digital Health Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-in-one health monitoring deviceDevice
The staff will use the new monitoring device to carry out the health monitoring on every day during the 12-week period. After each round of health monitoring by the traditional and the new devices, the staff will need to fill in log sheets designed by HKU to document the time consumed for the entire process.
| Study group | Role | What they receive |
|---|---|---|
| single-group | The health monitoring data of all the resident participants are measured using traditional device and the all-in-one health monitoring device on the same day for 12 weeks Receives: Device: All-in-one health monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time required for health monitoring operation during the 12-week period
The change in average daily operation time from using all-in-one health monitoring device compared to using traditional devices. The daily operation time from using all-in-one health monitoring device is recorded in log sheets by the staff.
Measured: 12 weeks
Secondary outcomes (3)
Qualitative measure: Perceived acceptance in using all-in-one health monitoring device
The staff, residents and/or family caregivers answer the following question in a semi-structured qualitative interview:
- Was it safe to use the new health monitoring device? (probing: how safe/ unsafe?)
- Do you want the new health monitoring device to be bigger or smaller? (probing: What is the problem for the current size? How much bigger/ smaller?)
- Was it easy or difficult to use the new health monitoring device? (probing: how easy/ difficult?)
- In the first place, to what degree did you expect the service users to comply with using the new health monitoring device?
- To what degree did you find the service users to comply with using the new health monitoring device?
Measured: at the end of 12-week trial period
Qualitative measure: Perceived benefits in using all-in-one health monitoring device
The staff, residents and/or family caregivers answer the following question in a semi-structured qualitative interview:
- Because of using the new health monitoring device, are there changes in the workflow and manpower logistics of vital signs recording?
- Is the workflow of vital signs recording done faster or slower? (probing: how much faster/ slower? if faster, by how much do the time saving meet your expectation?)
- Do you find (other) benefits in using the new health monitoring device?
Measured: at the end of 12-week trial period
Qualitative measure: Perceived concerns in using all-in-one health monitoring device
The staff, residents and/or family caregivers answer the following question in a semi-structured qualitative interview:
- In the first place, were you concerned about the new health monitoring device?
- Did you find these concerns in using the new health monitoring device? (probing: What were the events from which you confirm these concerns? Were the actual concerns larger or smaller than your expectations? If the event was malfunctioning, further probing: how did you or your colleagues fix it? How much time and effort was spent in fixing it?)
- Were there any unexpected concerns from using the new health monitoring device? (probing: What were the events from which you discover these concerns?)
- What suggestions would you make to future users of this health monitoring device to deal with these concerns?
Measured: at the end of 12-week trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start12 May 2022
- Primary completion19 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TechnologyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Haven of Hope Hospital, The Social Innovation and Entrepreneurship Development Fund, Hong Kong
- Responsible party
- Principal investigator, Dr. Derek Yee-Tak Cheung, The University of Hong Kong
- Investigators
- Yee Tak Cheung, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302895
- Sponsor's protocol ID
- HKU_healthmonitor_protocol_v3
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Research data and documentation will be available upon request.
Publications
Piau A, Campo E, Rumeau P, Vellas B, Nourhashemi F. Aging society and gerontechnology: a solution for an independent living? J Nutr Health Aging. 2014 Jan;18(1):97-112. doi: 10.1007/s12603-013-0356-5.
PubMed 24402399Carmeli, E. (2009). Aspects of assistive gerontechnology. International Journal on Disability and Human Development, 8(3), 215-218.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of an All-in-one Health Monitoring Device in Elderly Residential Setting
- ClinicalTrials.gov ID
- NCT05302895
- Acronym / sponsor ID
- HKU_healthmonitor_protocol_v3
- Conditions
- Technology
- Keywords
- Gerontechnology, Smart Healthcare Device, Digital Health Technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Haven of Hope Hospital, The Social Innovation and Entrepreneurship Development Fund, Hong Kong
- Study start
- 12 May 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-group | – | Device: All-in-one health monitoring deviceThe health monitoring data of all the resident participants are measured using traditional device and the all-in-one health monitoring device on the same day for 12 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study populations are residents in Haven of Hope Woo Ping Care \& Attention Home, residents in Haven of Hope Nursing Home, and nurses, health workers, and/or family members of the residents
Key inclusion criteria (8 listed)
- are responsible for the supervision of the health monitoring procedure and those who are responsible for the operation of daily health monitoring
- are able to hold the all-in-one health monitoring device with his/her thumbs and index fingers of both hands under the assistance of the staff
- Having participated in the main trial
- Having participated in the main trial
- Able to verbally communicate in Cantonese as perceived by the staff of the related home
Key exclusion criteria (7 listed)
- None
- Residents with implanted pacemakers and/or implanted cardio-defibrillators (ICDs)
- None
- None
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All-in-one health monitoring deviceThe staff will use the new monitoring device to carry out the health monitoring on every day during the 12-week period. After each round of health monitoring by the traditional and the new devices, the staff will need to fill in log sheets designed by HKU to document the time consumed for the entire process. | Device | single-group |
Primary outcome
Average time required for health monitoring operation during the 12-week period
Time frame: 12 weeks
The change in average daily operation time from using all-in-one health monitoring device compared to using traditional devices. The daily operation time from using all-in-one health monitoring device is recorded in log sheets by the staff.
3 secondary outcomes
Qualitative measure: Perceived acceptance in using all-in-one health monitoring device
Time frame: at the end of 12-week trial period
Qualitative measure: Perceived benefits in using all-in-one health monitoring device
Time frame: at the end of 12-week trial period
Qualitative measure: Perceived concerns in using all-in-one health monitoring device
Time frame: at the end of 12-week trial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 24402399Piau A, Campo E, Rumeau P, Vellas B, Nourhashemi F. Aging society and gerontechnology: a solution for an independent living? J Nutr Health Aging. 2014 Jan;18(1):97-112. doi: 10.1007/s12603-013-0356-5.
- BackgroundCarmeli, E. (2009). Aspects of assistive gerontechnology. International Journal on Disability and Human Development, 8(3), 215-218.
- Individual participant dataSharing planned: Yes. Research data and documentation will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yee Tak Cheung, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Technology, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average time required for health monitoring operation during the 12-week period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.