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

NCT05404802 | Completed

• 1 other identifier: HKU_robot_protocol_v3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Technology

Keywords

Gerontechnology; Smart Healthcare Device; Digital Health Technology

Outcome Measures

Primary Outcomes (2)

• 10 week change in neuropsychiatric symptoms after participating in 10-week PARO training program

  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.

  Baseline and the 10th week

• 10 week change in loneliness after participating in 10-week PARO training program

  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.

  Baseline and the 10th week

Secondary Outcomes (12)

• 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

• 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

• Qualitative Measure: Observed emotions

  3 PARO training sessions during the 10-week trial period

• Qualitative Measure: Observed engagement

  Every PARO training session and every free-play session during the 10-week trial period

• Qualitative Measure: Observed engagement (compliance)

  Every PARO training session during the 10-week trial period

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Device: Experimental group intervention

Control Group

EXPERIMENTAL

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.

Device: Control group intervention

Interventions

Experimental group intervention DEVICE

Training session Facilitators will facilitate participants' interaction with PARO for 7 main activities, namely: (1) hugging PARO; (2) expressing emotions to PARO: (3) remembering PARO; (4) feeding PARO; (5) sleeping PARO; (6) bathing PARO; (7) decorating PARO. Free-play session In these sessions, every participant can interact with one PARO without instructions but are under the safety supervision of a PARO facilitator.

Experimental Group

Control group intervention DEVICE

Facilitators will facilitate participants' interaction with PARO for 7 main activities, namely: (1) hugging PARO; (2) expressing emotions to PARO: (3) remembering PARO; (4) feeding PARO; (5) sleeping PARO; (6) bathing PARO; (7) decorating PARO.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Have participated in the main trial
• Able to verbally communicate in Cantonese as perceived by the staff of the related home
• None
• Have participated in the main trial
• 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 (2)

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

Hong Kong, 00, Hong Kong

Location

Haven of Hope Woo Ping Care & Attention Home

Hong Kong, 00, Hong Kong

Location

Related Publications (13)

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  PMID: 1202204 BACKGROUND

• Jones C, Sung B, Moyle W. Engagement of a Person with Dementia Scale: Establishing content validity and psychometric properties. J Adv Nurs. 2018 May 17. doi: 10.1111/jan.13717. Online ahead of print.

  PMID: 29772602 BACKGROUND

• Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.

  PMID: 11001602 BACKGROUND

• Lawton MP, Van Haitsma K, Klapper J. Observed affect in nursing home residents with Alzheimer's disease. J Gerontol B Psychol Sci Soc Sci. 1996 Jan;51(1):P3-14. doi: 10.1093/geronb/51b.1.p3.

  PMID: 8548515 BACKGROUND

• Pan IMY, Lau MS, Mak SC, Hariman KW, Hon SKH, Ching WK, Cheng KM, Chan CF. Staging of Dementia Severity With the Hong Kong Version of the Montreal Cognitive Assessment (HK-MoCA)'s. Alzheimer Dis Assoc Disord. 2020 Oct-Dec;34(4):333-338. doi: 10.1097/WAD.0000000000000399.

  PMID: 32701514 BACKGROUND

• Piau A, Campo E, Rumeau P, Vellas B, Nourhashemi F. Aging society and gerontechnology: a solution for an independent living? J Nutr Health Aging. 2014 Jan;18(1):97-112. doi: 10.1007/s12603-013-0356-5.

  PMID: 24402399 BACKGROUND

• Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

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• Carmeli E. Aspects of assistive gerontechnology. Int J Disabil Hum Dev. 2009; 8(3): 215-218.

  BACKGROUND

• Liu T, Lu S, Leung DKY, Sze LCY, Kwok WW, Tang JYM, Luo H, Lum TYS, Wong GHY. Adapting the UCLA 3-item loneliness scale for community-based depressive symptoms screening interview among older Chinese: a cross-sectional study. BMJ Open. 2020 Dec 10;10(12):e041921. doi: 10.1136/bmjopen-2020-041921.

  PMID: 33303463 BACKGROUND

• Yu DS. Insomnia Severity Index: psychometric properties with Chinese community-dwelling older people. J Adv Nurs. 2010 Oct;66(10):2350-9. doi: 10.1111/j.1365-2648.2010.05394.x. Epub 2010 Aug 16.

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• Morin CM. Insomnia: psychological assessment and management. Guilford press. 1993.

  BACKGROUND

• Wong ELY, Ramos-Goni JM, Cheung AWL, Wong AYK, Rivero-Arias O. Assessing the Use of a Feedback Module to Model EQ-5D-5L Health States Values in Hong Kong. Patient. 2018 Apr;11(2):235-247. doi: 10.1007/s40271-017-0278-0.

  PMID: 29019161 BACKGROUND

Study Officials

• Yee Tak Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be allocated to the experimental group or the control group according to their floor of the residential care homes. The participants in the experimental group will be arranged to join the PARO intervention in Week 1 to 10. The control group will be arranged to attend 2 PARO training sessions after all assessments are completed.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 3, 2022
• Study Start: June 20, 2022
• Primary Completion: September 9, 2022
• Study Completion: October 13, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

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

Locations

HK (2)