NCT05302440

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 5, 2024

Completed
Last Updated

July 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

March 21, 2022

Results QC Date

March 3, 2023

Last Update Submit

January 18, 2024

Conditions

Keywords

GerontechnologySmart Healthcare DeviceDigital Health Technology

Outcome Measures

Primary Outcomes (3)

  • 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): 3\. The remote real-time health monitoring system reduces your time for measuring vital signs of the residents in the previous shift

    every day during the 2-week trial period

  • 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): 2\. The remote real-time health monitoring system facilitates you to monitor the vital signs in the previous shift

    every day during the 2-week trial period

  • 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

    every day during the 2-week trial period

Secondary Outcomes (7)

  • Number of Hospital Admissions and Further Medical Assistance

    every day during the 2-week trial period

  • Average Perceived Staff Stress Level Over 14 Days

    every day during the 2-week trial period

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

    at the end of 2-week trial period

  • Number of Participants Agreeing That the Sensor Easily Detaches From the Participants

    at the end of 2-week trial period

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

    at the end of 2-week trial period

  • +2 more secondary outcomes

Study Arms (1)

single-group

All 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.

Device: remote real-time health monitoring system with ring-like sensor

Interventions

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.

single-group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • The Unit in-charge and care staff responsible to set up the system from each of the participating units will be recruited.
  • All care staff joining the main trial will be recruited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haven of Hope Nursing Home

Hong Kong, Hong Kong

Location

Kai Tak Holding Centre Zone D

Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 24402399BACKGROUND
  • Carmeli, E. Aspects of assistive gerontechnology. Int J Disabil Hum Dev. 2009; 8(3): 215-218.

    BACKGROUND

Results Point of Contact

Title
Dr. Derek Yee Tak CHEUNG
Organization
University of Hong Kong

Study Officials

  • Yee Tak Cheung, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

March 21, 2022

Primary Completion

May 9, 2022

Study Completion

May 9, 2022

Last Updated

July 5, 2024

Results First Posted

July 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Research data and documentation will be available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available for 10 years.

Locations