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TechnologyNCT05302440

The Perceived Efficiency and Acceptability of Remote Real-time Health Monitoring System in Elderly Residential Setting and Community Isolation Facility

An observational study of Technology, run by The University of Hong Kong at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study has 3 primary research questions and 6 secondary research questions targeting care staff in the setting of residential care homes for the elderly. The 3 primary research questions are: 1. Will care staff perceive the remote real-time health monitoring system with ring-like sensor as efficient? 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Technology
What is being tested?
remote real-time health monitoring system with ring-like sensor
Type of treatment
Medical device
How many people
20 participants
Where
2 sitesHong Kong
Study dates
21 Mar 2022to 9 May 2022
How long will I take part?
12 Weeks
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study populations are all care staff who are responsible to operate remote health monitoring system in Haven of Hope Woo Ping Care \& Attention Home and Haven of Hope Nursing Home.

Who may be able to join

  • All care staff in Haven of Hope Woo Ping Care \& Attention Home and Haven of Hope Nursing Home who are responsible to operate remote real-time health monitoring system will be invited to participate.
  • Inclusion Criteria for qualitative study about experience of setting up the system:
  • The Unit in-charge and care staff responsible to set up the system from each of the participating units will be recruited.
  • Inclusion Criteria for qualitative study about the operation of the system:
  • All care staff joining the main trial will be recruited.

Who cannot join

  • No

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites
  • Haven of Hope Nursing Home

    Hong Kong

  • Kai Tak Holding Centre Zone D

    Hong Kong

Other trials in Hong Kong

About this study

The study has 3 primary research questions and 6 secondary research questions targeting care staff in the setting of residential care homes for the elderly. The 3 primary research questions are:

  1. Will care staff perceive the remote real-time health monitoring system with ring-like sensor as efficient?
  2. Will the system facilitate any early detection of abnormal vital signs?
  3. Will the system facilitate early delivery of medical support? The 6 secondary research questions are:
  4. What are the numbers of hospital admissions and further medical assistance due to the adoption of the system?
  5. Will the system reduce the stress level of the care staff?
  6. What are the perceived benefits and acceptability of the care staff towards the system?
  7. What should be considered when developing the evaluation framework for the adaption of the system in elderly residential setting?
  8. Are there any barriers and difficulties in the set-up of the system?
  9. What are the concerns in choosing wireless or cable connection for the monitoring device?
Read the detailed description

Study design

This is a single-group 4-week trial of using the remote health monitoring system. All care staff who manage the system will complete a very brief survey (1-minute) after each work shift for 2 weeks. Detection of abnormal vital signs will be recorded by the system. Hospital admission and further medical assistance due to the adoption of the system will be documented by the care team. The care staff will be interviewed about their perceived benefits and acceptability of the system.

Subjects

Care staff in Haven of Hope Woo Ping Care \& Attention Home and Haven of Hope Nursing Home who are responsible to set up and operate real-time remote health monitoring system will be recruited. They also need to be able to read and understand Chinese.

Procedures

Implementation

The remote monitoring system will record the temperature, pulse and oxygen saturation (SpO2) of the residents wearing the equipment every minute. When the staff find abnormal vital signs, they will provide further medical assistance. After every shift during the trial period for 2 weeks, they will fill in a 1-minute survey.

Data collection

The remote monitoring system will remotely and real-time record the temperature, pulse and SpO2 of the residents wearing the sensor. The sensor is like a ring that wraps a finger. When the staff are notified of any abnormal vital signs by the system via screen display and notification sound, they will deliver further medical assistance. Hospital admission and further medical assistance due to the adoption of the system will be documented by the care team under pre-existing practice. After every shift during the trial period for 2 weeks, the staff will fill in a 1-minute survey about their operation and perceived efficiency of the system, such as facilitating more frequent monitoring of particular residents' vital signs, the provision of further medical assistance, perceived time saving in monitoring vital signs, and acceptability of the system. They could record their experience of using the system in a messaging mobile phone app in audio format. If they fill in the survey for fewer than 10 times during the 2 weeks, they would be invited to continue to fill in the survey after work shift after the 2 weeks until they fill in it for at least 10 times. Meanwhile, as a staff may complete more than 1 shift per day, they would not be invited to fill in the survey after having completed it for 12 items. All data collected that is related to residents is not identifiable.

There are two parts of the qualitative sub-study. When the system is set up, the unit in-charge and care staff responsible to set up the system from each participating unit will be interviewed by research assistant(s). Themes of qualitative questions include: (1) barriers and difficulties in the set-up of the system; and (2) the concerns in choosing wireless or cable connection for the monitoring device. Meanwhile, when the main trial ends, a total of 8-10 care staff from all participating units responsible to operate the system will be interviewed about their perceived benefits and acceptability of the system. Themes of qualitative questions include: (1) Acceptance of using the remote health monitoring system (including ease of operation, care staff's confidence and convenience in using the system); (2) Benefits of using the remote health monitoring system (including usefulness of the innovation, impacts on quality of care); (3) Concerns in using the remote health monitoring system (including if any residents stop using the sensor and the reason behind); and (4) Overall perception of using the remote health monitoring system. For both parts of the qualitative sub-study, an interview guide with open-ended and iterative questions will be used to probe for more experiences from the interviewees. Each interview will be conducted by a trained research assistant and will last about 15 - 30 minutes.

Blinding

Blinding is not applicable in this single group study.

Sample size determination

The sample size is estimated by the number and availability of the staff in the participating units. It is estimated that a total of 10-12 staff will be recruited.

Data analyses

The proportion of all the responses in the staff survey will be calculated. The number of abnormal vital signs, hospital admission and further medical assistance due to the adoption of the system will be counted.

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 system. The results will then be discussed and consolidated in the panel meetings with the co-authors.

Conditions
Technology
Being tested
remote real-time health monitoring system with ring-like sensor
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.

  • remote real-time health monitoring system with ring-like sensorDevice

    The remote monitoring system will constantly record the temperature, pulse and SpO2 of the residents wearing the equipment. When the staff find abnormal vital signs, they will provide further medical assistance. All care staff who manage the system will be complete a very brief survey (1-minute) after each work shift for 14 days.

Study groups in NCT05302440
Study groupRoleWhat they receive
single-groupAll care staff who manage the system will complete a very brief survey (1-minute) after each work shift for 14 days. Detection of abnormal vital signs will be recorded by the system. Hospital admission and further medical assistance due to the use of the system will be documented by the care team. The staff will be interviewed about their perceived benefits and acceptability of the system.
Receives: Device: remote real-time health monitoring system with ring-like sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Staff Perceived Overall Time-saving of the System Over 14 Days

    After every shift for 14 days, the staff fill in a survey for the following item with 5-point Likert scale (5= Strongly Agree, 1= Strongly Disagree):

    1. The remote real-time health monitoring system reduces your time for measuring vital signs of the residents in the previous shift

    Measured: every day during the 2-week trial period

  2. Average Staff Perception of the System on Early Detection of Abnormal Vital Signs Over 14 Days

    After every shift for 14 days, the staff fill in a survey for the following item with 5-point Likert scale (5= Strongly Agree, 1= Strongly Disagree):

    1. The remote real-time health monitoring system facilitates you to monitor the vital signs in the previous shift

    Measured: every day during the 2-week trial period

  3. Average Staff Perception of the System on Its Facilitation of Early Delivery of Medical Support Over 14 Days

    After every shift for 14 days, the staff fill in a survey for the following item with 5-point Likert scale (5= Strongly Agree, 1= Strongly Disagree):

    1. The remote real-time health monitoring system facilitates you to provide early delivery of medical support in the previous shift

    Measured: every day during the 2-week trial period

Secondary outcomes (7)
  1. Number of Hospital Admissions and Further Medical Assistance

    Number of hospital admissions and further medical assistance due to the use of the system, according to hospitalization record

    Measured: every day during the 2-week trial period

  2. Average Perceived Staff Stress Level Over 14 Days

    After every shift for 14 days, the staff fill in a survey for the following items with 5-point Likert scale (5= Strongly Agree, 1= Strongly Disagree) 4. The remote real-time health monitoring system has made you feel at ease in the previous shift (For example, you feel at ease as the system facilitates easy monitoring on the vital signs of the resident) 5. The remote real-time health monitoring system has made you feel uncomfortable in the previous shift (For example, you worry that residents might take off the sensor; bad connection or system malfunction) 6. The remote real-time health monitoring system relieves your stress in the previous shift

    Measured: every day during the 2-week trial period

  3. Number of Participants Agreeing That the System Can Remote Monitor the Vital Signs of the Participants

    During qualitative interviews, the number of participants agreeing that the system can remote monitor the vital signs of the participants

    Measured: at the end of 2-week trial period

  4. Number of Participants Agreeing That the Sensor Easily Detaches From the Participants

    During qualitative interviews, the number of participants agreeing that the sensor easily detaches from the participants

    Measured: at the end of 2-week trial period

  5. Number of Participants Agreeing That the Vital Signs Measured by the System Are Accurate

    During qualitative interviews, the number of participants agreeing that the vital signs measured by the system are accurate

    Measured: at the end of 2-week trial period

  6. Number of Participants Agreeing That the Size of the Sensors Fit the Participants

    During qualitative interviews, the number of participants agreeing that the size of the sensors fit the participants

    Measured: at the start of 2-week trial period

  7. Number of Participants Preferring Cable or Wireless Connection for the System

    During qualitative interviews, the number of participants preferring cable or wireless connection for the system

    Measured: at the start of 2-week trial period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start21 Mar 2022
  3. Primary completion9 May 2022
  4. Study completion9 May 2022

Resources

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
20 participants (actual)
Target duration
12 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302440
Sponsor's protocol ID
HKU_real-time_monitor_v3
Status last verified
Jan 2024
First submitted
21 Mar 2022
Last updated
5 Jul 2024
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 24402399
  • Carmeli, E. Aspects of assistive gerontechnology. Int J Disabil Hum Dev. 2009; 8(3): 215-218.

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 5 inclusion and 1 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 5 Jul 2024. 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?

Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Staff Perceived Overall Time-saving of the System Over 14 Days (time frame: every day during the 2-week trial period). The study lists 3 primary outcomes in all. 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 NCT05302440, 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 5 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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