The Effectiveness, Feasibility and Potential Risks of Resident Handling Devices in Elderly Residential Setting

NCT05789979 | Completed

• 1 other identifier: handling devices_protocol
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

1. 1.Can the new resident-handling devices improve resident comfortability during the resident-handling task?
2. 2.Are the new resident-handling devices perceived as safe compared to the conventional resident-handling devices?
3. 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?
4. 4.What are care staff attitudes towards the new and conventional resident-handling devices?
5. 5.What are the perceived difficulties in using the new and conventional resident-handling devices?
6. 6.What are the operation difficulties in the use of the new resident-handling devices in actual operation?
7. 7.What are the perceived benefits and feasibility of using the new resident-handling devices compared to conventional resident-handling devices?
8. 8.\[For resident-handling device for residents with low dependency only\] Can the new resident-handling device improve resident comfortability in functional activities?
9. 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. 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. 11.\[For resident-handling device for residents with high dependency only\] What is the average force exertion of care staff?
12. 12.\[For resident-handling device for residents with high dependency only\] How frequently does care staff exert excessive force (i.e. Ergo feedback)?

Conditions

Technology

Keywords

Gerontechnology; Resident handling devices; Elderly residential setting

Outcome Measures

Primary Outcomes (3)

• 5-week change in the level of comfort expressed by residents

  Care staff will complete an item indicating the level of comfort expressed by residents in using the conventional and new resident handling devices on a 5-point Likert scale (i.e. 1 indicating very uncomfortable and 5 indicating very comfortable). The minimum and maximum values of the scale are 1 and 5 respectively. Higher score indicates higher level of comfort.

  From the start of 1-week pre-test to the end of the 4-week trial period

• 5-week change in perceived safety

  Care staff will complete two items indicating the perceived safety in using the conventional and new resident handling devices on a 5-point Likert scale (i.e. 1 indicating very unsafety and 5 indicating very safety). The minimum and maximum values of the scale are 2 and 10 respectively, with higher score indicating higher level of safety.

  From the start of 1-week pre-test to the end of the 4-week trial period

• Qualitative measures: The potential risks to residents and staff involved in resident-handling tasks

  Potential risks to residents and care staff during the use of 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. 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. The contents include the preparation of residents and environment, the preparation of staff and tools, the operation process and the aftermath.

  Within a year before the 4-week trial to before the start of the 4-week trial

Secondary Outcomes (10)

• Care staff attitudes towards resident-handling devices

  From the start of 1-week pre-test to the end of the 4-week trial period

• Perceived easiness in using resident-handling devices

  From the start of 1-week pre-test to the end of the 4-week trial period

• Qualitative measures: The operation difficulties in the use of the new resident-handling devices in actual operation

  In the first week of the 4-week trial period

• Qualitative measures: The perceived benefits and feasibility of the resident-handling devices of residents

  At the end of the 4-week trial period

• Qualitative measures: The perceived benefits and feasibility of the resident-handling devices of care staff

  At the end of the 4-week trial period

Study Arms (1)

The resident-handling device

EXPERIMENTAL

This group will use the resident-handling device during the 4-week trial.

Device: The resident-handling device

Interventions

The resident-handling device DEVICE

Care staff will perform resident-handling tasks using the new resident-handling devices. For low dependency during 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. For high dependency during trial, when care staff are performing resident-handling tasks, the device moves with little force in any direction.

The resident-handling device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• The University of Hong Kong: lead
• Haven of Hope Hospital: collaborator
• The Social Innovation and Entrepreneurship Development Fund, Hong Kong: collaborator

Study Sites (3)

Haven of Hope Hang Hau Care and Attention Home for Severely Disabled

Hong Kong, 00, Hong Kong

Location

Haven of Hope Nursing Home

Hong Kong, 00, Hong Kong

Location

Haven of Hope Sister Annie Skau Holistic Care Centre

Hong Kong, 00, Hong Kong

Location

Study Officials

• Yee Tak Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: March 13, 2023
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for 10 years.

Locations

HK (3)