- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05302440
The Perceived Efficiency and Acceptability of Remote Real-time Health Monitoring System With Ring-like Sensor in Elderly Residential Setting
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:
- Will care staff perceive the remote real-time health monitoring system with ring-like sensor as efficient?
- Will the system facilitate any early detection of abnormal vital signs?
Will the system facilitate early delivery of medical support?
The 6 secondary research questions are:
- What are the numbers of hospital admissions and further medical assistance due to the adoption of the system?
- Will the system reduce the stress level of the care staff?
- What are the perceived benefits and acceptability of the care staff towards the system?
- What should be considered when developing the evaluation framework for the adaption of the system in elderly residential setting?
- Are there any barriers and difficulties in the set-up of the system?
- What are the concerns in choosing wireless or cable connection for the monitoring device?
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- Haven of Hope Nursing Home
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Hong Kong, Hong Kong
- Haven of Hope Sister Annie Skau Holistic Care Centre
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Hong Kong, Hong Kong
- Haven of Hope Woo Ping Care & Attention Home
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Hong Kong, Hong Kong
- Kai Tak Holding Centre Zone D
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for main trial:
- 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.
Exclusion Criteria:
- No
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average staff perceived overall time-saving of the system over 14 days
Time Frame: every day during the 2-week trial period
|
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
Time Frame: every day during the 2-week trial period
|
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
Time Frame: every day during the 2-week trial period
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of hospital admissions and further medical assistance
Time Frame: every day during the 2-week trial period
|
Number of hospital admissions and further medical assistance due to the use of the system, according to hospitalization record
|
every day during the 2-week trial period
|
Average perceived staff stress level over 14 days
Time Frame: every day during the 2-week trial period
|
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
|
every day during the 2-week trial period
|
Qualitative measure: Perceived benefits of the system
Time Frame: at the end of 2-week trial period
|
The staff answers the following question in a semi-structured qualitative interview:
|
at the end of 2-week trial period
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Qualitative measure: Perceived acceptability of the system
Time Frame: at the end of 2-week trial period
|
The staff answers the following question in a semi-structured qualitative interview:
|
at the end of 2-week trial period
|
Qualitative measure: Perceived concerns of the system
Time Frame: at the end of 2-week trial period
|
The staff answers the following question in a semi-structured qualitative interview:
|
at the end of 2-week trial period
|
Qualitative measure: Barriers and difficulties in the set-up of the system
Time Frame: at the start of 2-week trial period
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The staff answers the following question in a semi-structured qualitative interview: 1. What are the barriers and difficulties you have encountered when you install the system and help residents to wear the sensor (Probing questions: How did you solve these problems? Possible obstacles and difficulties include bad connection, insufficient space in the office area, and problem concerning the server) |
at the start of 2-week trial period
|
Qualitative measure: concerns in choosing wireless or cable connection for the system
Time Frame: at the start of 2-week trial period
|
The staff answers the following question in a semi-structured qualitative interview: As the ring-like sensor can be connected through wireless connection and cable connection, which connection method did you choose? What kind of factors would you take into consideration when making the aforementioned decision? |
at the start of 2-week trial period
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Carmeli, E. Aspects of assistive gerontechnology. Int J Disabil Hum Dev. 2009; 8(3): 215-218.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HKU_real-time_monitor_v1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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