跳至主要内容
临床试验/NCT05404802
NCT05404802已完成不适用

Therapeutic Effectiveness of PARO Companion Robot for Elderly With Mild Cognitive Impairment/Dementia in Elderly Residential Setting: A Quasi-experimental Study

The University of Hong Kong4 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
4
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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Derek Yee-Tak Cheung

Assistant Professor

The University of Hong Kong

研究点 (4)

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