The Perceived Efficiency and Acceptability of Remote Real-time Health Monitoring System With Ring-like Sensor in Elderly Residential Setting

Technology Clinical Trial

Official title:

The Perceived Efficiency and Acceptability of Remote Real-time Health Monitoring System With Ring-like Sensor in Elderly Residential Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05302440
• Other study ID #: HKU_real-time_monitor_v1
• Status: Completed
• Start date: March 21, 2022
• Est. completion date: May 9, 2022

Study information

• Verified date: July 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Technology

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Hong Kong	Haven of Hope Nursing Home	Hong Kong
Hong Kong	Haven of Hope Sister Annie Skau Holistic Care Centre	Hong Kong
Hong Kong	Haven of Hope Woo Ping Care & Attention Home	Hong Kong
Hong Kong	Kai Tak Holding Centre Zone D	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Haven of Hope Hospital, The Social Innovation and Entrepreneurship Development Fund, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

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

Piau A, Campo E, Rumeau P, Vellas B, Nourhashémi 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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	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	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	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	every day during the 2-week trial period
Secondary	Qualitative measure: Perceived benefits of the system	The staff answers the following question in a semi-structured qualitative interview: Because of using the remote real-time 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 think that the use of remote real-time health monitoring system is helpful in facilitating early detection of abnormal vital signs of residents? How can it help you? / Why can't it help you?; Do you think that the use of remote real-time mentoring system is helpful in providing immediate assistance to the residents? How can it help you? / Why can't it help you?; Do you find (other) benefits in using the remote real-time health monitoring device?	at the end of 2-week trial period
Secondary	Qualitative measure: Perceived acceptability of the system	The staff answers the following question in a semi-structured qualitative interview: Was it safe to use the remote real-time health monitoring device? (probing: how safe/ unsafe?); How often do you charge the sensor? Do you have to take off the sensor in order to charge it? Is it easy to wear and take off the sensor from the residents? Is it convenient? (probing: How easy / difficult was that? Are you confident in helping the residents to wear and take off the sensor smoothly?); In the first place, do you expect the sensor to be detached from the residents easily? (For example: residents take off the sensor or the sensor slips off accidentally); Do you think that the sensor get detached from the residents easily?; Under what circumstance would the system increase your stress level?; Under what circumstance would the system reduce your stress level?; On the whole, do you think that the monitoring system increase or reduce your stress level?	at the end of 2-week trial period
Secondary	Qualitative measure: Perceived concerns of the system	The staff answers the following question in a semi-structured qualitative interview: In the first place, what were your concerned about the remote real-time health monitoring device?; Did you find these concerns while using the system? (probing: How did you realize these concerns? Were they more serious than your expectation? In the case of the system malfunction. How did you fix it? Was it successful? How long did you spend?; Were there any unexpected problems from using the remote real-time health monitoring device? (probing: When did discover these problems?); What suggestions would you make to future users of the remote real-time health monitoring device to deal with these concerns?	at the end of 2-week trial period
Secondary	Qualitative measure: Barriers and difficulties in the set-up of the system	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
Secondary	Qualitative measure: concerns in choosing wireless or cable connection for the system	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