The Effectiveness, Feasibility and Potential Risks of Resident Handling Devices in Elderly Residential Setting: A Single Group Pre-post Test Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- 5-week change in the level of comfort expressed by residents
研究概览
简要总结
The study has 12 research questions regarding the use of resident-handling device in elderly residential setting:
Primary study questions:
- Can the new resident-handling devices improve resident comfortability during the resident-handling task?
- Are the new resident-handling devices perceived as safe compared to the conventional resident-handling devices?
- 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)?
详细描述
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
- Residents
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Exclusion criteria for high dependency device, low dependency device and care staff:
结局指标
主要结局
5-week change in the level of comfort expressed by residents
时间窗: From the start of 1-week pre-test to the end of the 4-week trial period
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.
5-week change in perceived safety
时间窗: From the start of 1-week pre-test to the end of the 4-week trial period
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.
Qualitative measures: The potential risks to residents and staff involved in resident-handling tasks
时间窗: Within a year before the 4-week trial to before the start of the 4-week trial
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.
次要结局
- 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 potential risks to residents with low dependency and staff when the device is used for functional activities(Within a year before the 4-week trial to before the start of the 4-week trial)
- Care staff attitudes towards resident-handling devices(From the start of 1-week pre-test to the end 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)
- Perceived safety of residents with low dependency on using the functional activities(From the start of 1-week pre-test to the end of the 4-week trial period)
- The number of Ergo feedback (a proxy measure of the number of times care staff use excessive force) of residents with high dependency(From the start to 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)
- Perceived easiness in using resident-handling devices(From the start of 1-week pre-test to the end of the 4-week trial period)
- The level of comfort expressed by residents with low dependency on using the functional activities(From the start of 1-week pre-test to the end of the 4-week trial period)
- The average force exertion of care staff on residents with high dependency(From the start to the end of the 4-week trial period)
研究者
Dr. Derek Yee-Tak Cheung
Principal Investigator, Assistant Professor
The University of Hong Kong