Therapeutic Effectiveness of PARO Companion Robot for Elderly With Mild Cognitive Impairment/Dementia in Elderly Residential Setting: A Quasi-experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- 10 week change in neuropsychiatric symptoms after participating in 10-week PARO training program
研究概览
简要总结
The main trial is a 2-group quasi-experimental trial of comparing the outcome indicators between joining and not joining the 10-week personal assistive robot (PARO) training program in residents with dementia or mild cognitive impairment (MCI). The study questions are as follows:
Primary study questions:
i. Can participation of the 10-week PARO training program reduce neuropsychiatric symptoms at week 10?
ii. Can participation of the 10-week PARO training program reduce loneliness at week 10?
Secondary study questions:
iii. Can participation of PARO training session reduce pulse rate (as an indicator of stress and anxiety)?
iv. Can participation of PARO training session improve oxygen saturation (as an indicator of stress and anxiety)?
v. What are the participants' emotions and engagement in PARO training sessions?
Auxiliary study questions:
vi. Can participation of the 10-week PARO training program reduce neuropsychiatric symptoms at week 14?
vii. Can participation of the 10-week PARO training program reduce loneliness at week 14?
viii. Can participation of the 10-week PARO training program improve quality of life at week 10?
ix. Can participation of the 10-week PARO training program improve quality of life at week 14?
x. Can participation of the 10-week PARO training program improve sleep quality at week 10?
xi. Can participation of the 10-week PARO training program improve sleep quality at week 14?
xii. Can participation of the 10-week PARO training program improve cognitive functioning at week 10?
xiii. Can participation of the 10-week PARO training program improve cognitive functioning at week 14?
xiv. What are the feelings, satisfaction, and acceptance of PARO of the participants and PARO facilitators?
详细描述
Study design
This is a 2-group quasi-experimental trial of comparing the outcome indicators between joining and not joining the 10-week PARO training program in residents with dementia or mild cognitive impairment (MCI) in Haven of Hope Woo Ping Care & Attention Home. Residents from the Haven of Hope Hang Hau Care and Attention Home for Severely Disabled will also be recruited and join the PARO training program, but their data will be analysed independently. The feelings, satisfaction, and acceptance of PARO of the participants and PARO facilitators.
Procedures
Training of PARO facilitators
Nurses, social workers, occupational therapists, health care assistants and program workers of the service units will be recruited and trained as PARO facilitators. The formal PARO facilitator training lasts for about 3 hours. An intervention protocol will be provided for the facilitators in running the training sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants, training session moderators and observers of PARO sessions cannot and will not be blinded to the intervention. Assessors of the follow-up outcomes and the research analysts will not be involved in the recruitment and intervention delivery and will be blinded to the group allocation (single blindness).
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for residents in main trial:
- •Is diagnosed with mild to moderate dementia by doctors
- •Score at least 5 (Pan et al., 2020) and lower than the norm-derived age and education adjusted cutoff scores 7th percentile in HK-MoCA (Wong et al., 2015), non-dementia patients
排除标准
- •for residents in main trial:
- •Have unstable physical or psychological conditions as advised by doctors or nurse in charge
- •Have severe medical conditions which limit the ability to participate in the PARO sessions
- •Have visual or hearing impairment that interfere with cognitive intervention
- •Fear or reluctance in using robots
- •Unable to communicate
- •Inclusion Criteria for residents in qualitative interviews:
- •Have participated in the main trial
- •Able to verbally communicate in Cantonese as perceived by the staff of the related home
- •Exclusion Criteria for residents in qualitative interviews:
- •Inclusion Criteria of PARO facilitator for qualitative interviews:
- •Have participated in the main trial
- •Exclusion Criteria for PARO facilitator in qualitative interviews:
研究组 & 干预措施
Experimental Group
Training sessions
Each training session will last for 30-45 minutes, twice a week over a 10-week period in Week 1 to Week 10. Each session will be attended by a cluster of 4 to 6 participants, and each participant will have one PARO.
Free-play sessions
Two 15-30 minutes free-play sessions in each week of the 10 weeks are conducted on days when there are no training sessions.
干预措施: Experimental group intervention (Device)
Control Group
Training sessions
Each training session will last for 30-45 minutes, once a week over a 2-week period after all assessments are completed. Each session will be attended by a cluster of 4 to 6 participants, and each participant will have one PARO.
There is no free-play sessions for control group.
干预措施: Control group intervention (Device)
结局指标
主要结局
10 week change in neuropsychiatric symptoms after participating in 10-week PARO training program
时间窗: Baseline and the 10th week
Change of neuropsychiatric symptoms after participating in 10-week PARO training program will be measured by Neuropsychiatric Inventory Questionnaire (NPI-Q; Cummings, et al., 1994; Kauffer, 1999). The range of the the severity scale is 12 to 36, with higher score indicating more severe neuropsychiatric symptoms. The range of the caregiver distress scale is 0 to 60, with higher score indicating higher caregiver distress.
10 week change in loneliness after participating in 10-week PARO training program
时间窗: Baseline and the 10th week
Change of loneliness after participating in 10-week PARO training program will be measured by UCLA Loneliness Scale 3 items (UCLA 3-items, Russell et al., 1980; Liu et al., 2020). The minimum and maximum values of the scale are 3 and 9 respectively, with higher score indicating higher level of loneliness.
次要结局
- Qualitative Measure: Observed engagement (compliance)(Every PARO training session during the 10-week trial period)
- Change in cognitive functions after participating in 10-week PARO training program(Baseline, the 10th week and 14th week)
- Qualitative Measure: Perceived feelings, satisfaction and acceptance on companion robot by the participants(within 2 weeks after week 10)
- Change in feelings of stress and anxiety as indicated by oxygen saturation after participating in PARO training session(Before and after the three training sessions during the 10-week trial period)
- Change in quality of life after participating in 10-week PARO training program(Baseline, the 10th week and 14th week)
- Qualitative Measure: Observed emotions(3 PARO training sessions during the 10-week trial period)
- Change in feelings of stress and anxiety as indicated by pulse rate after participating in PARO training session(Before and after the three training sessions during the 10-week trial period)
- 14 week change in neuropsychiatric symptoms after participating in 10-week PARO training program(Baseline and 14th week)
- Change in sleep quality after participating in 10-week PARO training program(Baseline, the 10th week and 14th week)
- Qualitative Measure: Observed engagement(Every PARO training session and every free-play session during the 10-week trial period)
- 14 week change in loneliness after participating in 10-week PARO training program(Baseline and 14th week)
- Qualitative Measure: Perceived feelings, satisfaction and acceptance on companion robot by the PARO facilitators(within 2 weeks after week 10)
研究者
Dr. Derek Yee-Tak Cheung
Assistant Professor
The University of Hong Kong