Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Haven of Hope Hospital | OTHER |
| The Social Innovation and Entrepreneurship Development Fund, Hong Kong | OTHER |
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote real-time health monitoring system with ring-like sensor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | every day during the 2-week trial period |
| Average Perceived Staff Stress Level Over 14 Days |
Not provided
Inclusion Criteria for main trial:
Inclusion Criteria for qualitative study about experience of setting up the system:
Inclusion Criteria for qualitative study about the operation of the system:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yee Tak Cheung, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haven of Hope Nursing Home | Hong Kong | Hong Kong | ||||
| Kai Tak Holding Centre Zone D |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24402399 | Background | 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. | |
| Background | Carmeli, E. Aspects of assistive gerontechnology. Int J Disabil Hum Dev. 2009; 8(3): 215-218. |
Not provided
Not provided
Research data and documentation will be available upon request.
Data will be available for 10 years.
Not provided
Not provided
Failure to read and understand Chinese will deter smooth communication and undermine the objectivity of the study
The participants will be recruited in the elderly residential setting and community isolation facility. The recruitment period of each test sites is one week. They also need to be able to read and understand Chinese.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. remote real-time health monitoring system with ring-like sensor: The remote monitoring system will constantly record the temperature, pulse and oxygen saturation (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2022 |
Not provided
Not provided
Not provided
Not provided
|
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 |
| 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 | at the end of 2-week trial period |
| 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 | at the end of 2-week trial period |
| 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 | at the end of 2-week trial period |
| 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 | at the start of 2-week trial period |
| 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 | at the start of 2-week trial period |
| Hong Kong |
| Hong Kong |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. remote real-time health monitoring system with ring-like sensor: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | Scores on a scale | every day during the 2-week trial period |
|
|
| ||||||||||||||||||||||||||
| Primary | 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 | Posted | Mean | Standard Deviation | Scores on a scale | every day during the 2-week trial period |
|
| |||||||||||||||||||||||||||
| Primary | 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 | Posted | Mean | Standard Deviation | Scores on a scale | every day during the 2-week trial period |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | events | every day during the 2-week trial period |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Mean | Standard Deviation | Scores on a scale | every day during the 2-week trial period |
| ||||||||||||||||||||||||||||
| Secondary | 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 | Interviews were conducted with 6 participants. 2 participants were invited from each of the service unit. | Posted | Count of Participants | Participants | at the end of 2-week trial period |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Interviews were conducted with 6 participants. 2 participants were invited from each of the service unit. | Posted | Count of Participants | Participants | at the end of 2-week trial period |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Interviews were conducted with 6 participants. 2 participants were invited from each of the service unit. | Posted | Count of Participants | Participants | at the end of 2-week trial period |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Interviews were conducted with 6 participants. 2 participants were invited from each of the service unit. | Posted | Count of Participants | Participants | at the start of 2-week trial period |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Interviews were conducted with 6 participants. 2 participants were invited from each of the service unit. | Posted | Count of Participants | Participants | at the start of 2-week trial period |
|
|
During the 4-week trial periods in each test site
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. remote real-time health monitoring system with ring-like sensor: 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. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Derek Yee Tak CHEUNG | University of Hong Kong | 3917 6652 | derekcheung@hku.hk |
| Jan 18, 2024 |
| Prot_SAP_000.pdf |
| 50-59 years |
|
| ≥60 years |
|
| Did not report |
|
| Did not report |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|