Clinical trial NCT05789979: The Effectiveness, Feasibility and Potential Risks of Resident Handling Devices in Elderly Residential Setting
Official title: The Effectiveness, Feasibility and Potential Risks of Resident Handling Devices in Elderly Residential Setting: A Single Group Pre-post Test Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Technology
Keywords: Gerontechnology
Resident handling devices
Elderly residential setting
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Haven of Hope Hospital
name: The Social Innovation and Entrepreneurship Development Fund, Hong Kong
First posted: 2023-03-29
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The trial is a single group pre-post test study at HOH Nursing Home (NH), Sister Annie Skau Holistic Care Centre (SASHCC), and Care \& Attention Home for Severely Disabled (CASD). During the 4-week trial, one floor in SASHCC and one floor in NH will utilize the resident-handling device for residents with high dependency (i.e., lower-limb cannot bear weight). CASD and another floor in NH will use the resident-handling device for residents with low dependency (i.e. lower-limb can bear weight). Outcome indicators are examined during the 1-week pre-test the 4-week trial. Additionally, opinions and comments from care staff and residents regarding the new resident-handling devices will be collected at the end of the trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study has 12 research questions regarding the use of resident-handling device in elderly residential setting:

Primary study questions:

1. Can the new resident-handling devices improve resident comfortability during the resident-handling task?
2. Are the new resident-handling devices perceived as safe compared to the conventional resident-handling devices?
3. What are the potential risks to the residents and care staff involve in the resident-handling tasks using the new and conventional resident-handling devices?

   Secondary study questions:
4. What are care staff attitudes towards the new and conventional resident-handling devices?
5. What are the perceived difficulties in using the new and conventional resident-handling devices?

   Auxiliary study questions:
6. What are the operation difficulties in the use of the new resident-handling devices in actual operation?
7. What are the perceived benefits and feasibility of using the new resident-handling devices compared to conventional resident-handling devices?
8. \[For resident-handling device for residents with low dependency only\] Can the new resident-handling device improve resident comfortability in functional activities?
9. \[For resident-handling device for residents with low dependency only\] Is the new resident-handling device perceived as safe for functional activities compared to the conventional resident-handling devices?
10. \[For resident-handling device for residents with low dependency only\] What are the potential risks to the residents and care staff involve in functional activities using the new and conventional resident-handling devices?
11. \[For resident-handling device for residents with high dependency only\] What is the average force exertion of care staff?
12. \[For resident-handling device for residents with high dependency only\] How frequently does care staff exert excessive force (i.e. Ergo feedback)?

Detailed description: Study design

The trial is a single group pre-post test study at Haven of Hope (HOH) Nursing Home (NH), Sister Annie Skau Holistic Care Centre (SASHCC), and Care \& Attention Home for Severely Disabled (CASD). During the 4-week trial, one floor in SASHCC and one floor in NH will utilize the resident-handling device for residents with high dependency (i.e., lower-limb cannot bear weight). CASD and another floor in NH will use the resident-handling device for residents with low dependency (i.e. lower-limb can bear weight). Outcome indicators are examined during the 1-week pre-test the 4-week trial. Additionally, opinions and comments from care staff and residents regarding the new resident-handling devices will be collected at the end of the trial.

This protocol complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki.

Subjects

1. Residents

   Residents of two selected floors at Nursing Home (NH), Care \& Attention for Severely Disabled (CASD), and Sister Annie Skau Holistic Care Centre (SASHCC) will be recruited.

   Inclusion criteria for high dependency device:

   • Lower limb cannot bear weight,
   * Assessed by health care workers (e.g., occupational therapists, physiotherapists, nurses) that manual handling is not appropriate
   * According to the study site instruction, require the use of resident handling device

   Exclusion criteria:
   * None

   Inclusion criteria for low dependency device:

   • Lower-limb can bear weight

   • Assessed by health care workers (e.g., occupational therapists, physiotherapists, nurses) that manual handling is not appropriate

   • According to the study site instruction, require the use of resident handling device

   Exclusion criteria:

   • None
2. Care staff Care staff of two selected floors at Nursing Home (NH), Care \& Attention for Severely Disabled (CASD), and Sister Annie Skau Holistic Care Centre (SASHCC) will be recruited.

Inclusion criteria:

• Responsible for transferring and lifting residents using any of the new resident handling devices

Exclusion criteria:

• None

Procedures

1. Participants' recruitment and consent

   The criteria stated in the Alzheimer Europe Report (2011) will be followed to ensure that the participants are provided chances to give consent. In particular, four criteria will be evaluated, including 1) the person must have sufficient capacity to understand the information, 2) the person is able to retain, use and weight up such information for making a decision, 3) the person will understand the benefit, risk, and convenience, 4) the person must have the ability to communicate the decision. The University of Hong Kong (HKU) research staff and the care staff will first commit them in a causal chat to assess their ability to communicate and understand the dialogues. If residents meet all the four criteria, both residents and their next of kin will be approached for consent. Otherwise, only their next of kin will be approached for consent.

   For the residents who will be approached for consent, the HKU research staff will elaborate the study based on the opt-out consent script and give them the opt-out consent document. Neither HKU nor the supplier will get personal or sensitive information of the participants due to the study. If they do not want to participate, they can notify the care staff. Unless they indicate withdrawal from the study, they are treated as consenting to join the study (opt-out participation). Every time before using the devices, the care staff will inform the use of the devices. Devices will be used only when participants do not raise objections.

   Their next of kin will be informed of the new devices and the study through standard channel of the test site (i.e. messaging mobile phone app or phone). If they do not want the residents to participate, they can notify the care staff. Unless they indicate withdrawal from the study, they are treated as consenting the residents to join the study (opt-out participation).

   For the care staff, it will be presumed that they agree to participate in the study if they complete the anonymous questionnaire (implied consent).

   Before qualitative interviews with the participants, written consent will be obtained from them and their next of kin. Before qualitative interviews with the care staff, written consent will be obtained from them.
2. Baseline data collection

   Before the trial, all test sites use the conventional resident-handling devices available in their service units. In the week before the trial, the baseline data of the level of comfort during transfer and lifting, care staff attitudes towards the conventional resident-handling devices and perceived difficulties in using conventional resident-handling devices will be collected. It is a standard practice for the study site to require all staff operating the devices to pass yearly audit to ensure that they can operate the devices properly. Potential risks to residents and care staff during using the conventional resident-handling device resident-handling and/or functional activities will be assessed based on the audit reports in last year. The safety audit reports will be provided by study site manager.
3. Training of resident-handling device for care staff

   A few 1.5- to 2-hour trainings on the use of resident-handling device will be delivered to all care staff. During the training, care staff will learn how to use the device with hands-on experience. Also, the product supplier will provide a 10-minute demonstration video for care staff to better understand the operation procedure. A protocol detailing related device operations will be prepared for the staff.
4. Safety audit

   After the staff training, care staff who are responsible for transferring and lifting residents using the new resident-handling devices will be audited by clinical professionals (e.g., occupational therapists, physiologists) to ensure that they can operate the devices properly. The audit items are developed based on the experience of using and auditing various types and models of resident-handling devices of the study sites, and are in use for years. The audit takes around 2 to 3 weeks to complete. Potential risks to residents and care staff during using the new resident-handling device for resident-handling and/or functional activities will be assessed based on the audit reports. The safety audit reports will be provided by study site manager.
5. Implementation

   Care staff at one selected floor of Nursing Home (NH) and Care \& Attention for Severely Disabled (CASD) will use the resident handling device for participants with low dependency during the 4-week trial. The device helps care staff to assist residents in making a transition from a sit to a standing posture, vice versa. This device is used for functional activities and transferring and lifting participants.

   On the other hand, care staff at another selected floor at Nursing Home (NH) and Sister Annie Skau Holistic Care Centre (SASHCC) will use the resident handling device for residents with high dependency during the 4-week trial. When care staff are performing resident handling tasks, the device moves with little force in any direction. The handlebar's force sensors detect and transfer force in the appropriate directions, speeding up the 5th wheel below. There will be a real-time alert if the care staff pushes or pulls at a force more than 20 kilogram (which should not be exceeded as per the recommendation of Occupational Safety and Health Council).
6. Trial data collection

In the first trial week, clinical consultant(s) will observe the actual operation for once for each device model to investigate operation difficulties, and record the observations in an observation report. Operation protocol may be revised. A 5 to 15 minutes follow-up staff training may be delivered to all care staff based on the revised protocol.

During the 4-week trial, care staff will complete a self-administrated questionnaire about the level of comfort expressed by residents and perceived safety when they perform resident handling and/or functional activities using the resident handling device every week.

At the end of the trial, 2 to 4 residents and 3 to 4 cares staff at each test site will be selected by convenience and invited to an interview. Interview contents include the perceived benefits and feasibility of new resident handling devices compared to conventional resident handling devices. For the resident handling device for participants with high dependency, data of care staff's average force exertion and number of Ergo feedback (a proxy measure of number of times care staff use excessive force) will be retrieved.

Blinding

No blinding will be done for this single group study.

Sample size determination

The sample size is estimated by the current number of care staff who are responsible for resident handling tasks and residents who require the use of resident handling device at the study sites. It is estimated that a total of 35 residents and 28 care staff will be using the resident handling device for residents with high dependency, while a total of 22 residents and 35 care staff will be using the resident handling device for residents with low dependency.

Data analysis

1. Main analysis

   Independent sample t-test will be used to evaluate the change in the anonymous pre-post data of level of comfort expressed by residents, perceived safety, care staff attitudes towards the resident-handling device and perceived difficulties in using of new resident-handling device. Independent sample t-test with Bonferroni correction will be used to evaluate the change in the anonymous weekly data of level of comfort expressed by residents, perceived safety, care staff attitudes towards the resident-handling device and perceived difficulties in using of new resident-handling device.

   Safety audit reports regarding the potential risks involved in the resident-handling tasks and functional activities during pre-test and trial period will be compared.

   Descriptive statistics will used to show the average force that care staff exert and number of Ergo feedback (a proxy measure of number of times care staff use excessive force) generated by the device.

   The operation difficulties in the use of the new resident-handling devices in actual operation will be summarised.
2. Qualitative interview

The content will be transcribed verbatim in Chinese for further analysis. Transcripts will be analysed using framework analysis to construct a coherent and logical structure from the classification of many opinions and perceptions of the new and conventional resident-handling device. The results will then be discussed and consolidated in the panel meetings with the co-authors.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for high dependency device:

* Lower limb cannot bear weight,
* Assessed by health care workers (e.g., occupational therapists, physiotherapists, nurses) that manual handling is not appropriate
* According to the study site instruction, require the use of resident-handling device

Inclusion criteria for low dependency device:

* Lower-limb can bear weight
* Assessed by health care workers (e.g., occupational therapists, physiotherapists, nurses) that manual handling is not appropriate
* According to the study site instruction, require the use of resident-handling device

Inclusion criteria for care staff:

• Responsible for transferring and lifting residents using any of the new resident-handling devices

Exclusion Criteria:

Exclusion criteria for high dependency device, low dependency device and care staff:

• None

Primary outcomes:
measure: 5-week change in the level of comfort expressed by residents
timeFrame: From the start of 1-week pre-test to the end of the 4-week trial period
measure: 5-week change in perceived safety
timeFrame: From the start of 1-week pre-test to the end of the 4-week trial period
measure: Qualitative measures: The potential risks to residents and staff involved in resident-handling tasks
timeFrame: Within a year before the 4-week trial to before the start of the 4-week trial
Secondary outcomes:
measure: Care staff attitudes towards resident-handling devices
timeFrame: From the start of 1-week pre-test to the end of the 4-week trial period
measure: Perceived easiness in using resident-handling devices
timeFrame: From the start of 1-week pre-test to the end of the 4-week trial period
measure: Qualitative measures: The operation difficulties in the use of the new resident-handling devices in actual operation
timeFrame: In the first week of the 4-week trial period
measure: Qualitative measures: The perceived benefits and feasibility of the resident-handling devices of residents
timeFrame: At the end of the 4-week trial period
measure: Qualitative measures: The perceived benefits and feasibility of the resident-handling devices of care staff
timeFrame: At the end of the 4-week trial period
measure: The level of comfort expressed by residents with low dependency on using the functional activities
timeFrame: From the start of 1-week pre-test to the end of the 4-week trial period
measure: Perceived safety of residents with low dependency on using the functional activities
timeFrame: From the start of 1-week pre-test to the end of the 4-week trial period
measure: Qualitative measures: The potential risks to residents with low dependency and staff when the device is used for functional activities
timeFrame: Within a year before the 4-week trial to before the start of the 4-week trial
measure: The average force exertion of care staff on residents with high dependency
timeFrame: From the start to the end of the 4-week trial period
measure: The number of Ergo feedback (a proxy measure of the number of times care staff use excessive force) of residents with high dependency
timeFrame: From the start to the end of the 4-week trial period
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Hang Hau Care and Attention Home for Severely Disabled
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Nursing Home
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Sister Annie Skau Holistic Care Centre
Study officials:
affiliation: The University of Hong Kong
name: Yee Tak Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: