NCT06487611

Brief Summary

Background Older adults experience significant physical, cognitive and environmental losses in their later life. Self-supported 'aging-in-place' has benefits for mental health and the quality of life for older people. In the field of gerontological nursing, person-centered holistic care highlights the importance of enabling older people and their significant others (such as older spouse or other family caregivers) to establish healthful relationships so to improve older adults' physical, psychological, mental and social wellbeing. However, globally and also most recommended by Hong Kong government, home-based care services for older adults have not been fully developed. Research on the use of robots supporting older adults is given increasing attention in the globe, but most of them were focused on aiding older adults who are living with dementia or residing in nursing homes. More robotic research needs to be conducted at their own homes in the community and support older people in having an independent lifestyle. Study Aim This study aims to investigate the feasibility and acceptability of home-based physical robot HUMANE by community-dwelling Chinese older adults and soon-to-be-aged adults and their family caregivers. Study design and method This study will employ a two-arm pilot randomized control trial with qualitative interviews. People aged 50 or above who are receiving home care from family members will be recruited to this study. Purposive sampling will be adopted in recruitment. The robot HUMANE will be used by the intervention group for a 6-week trial. Loneliness, cognitive function, emotional status, self-efficacy, mutuality and sense of coherence will be measured at baseline (day-1) and immediately post-intervention (week-6) to examine preliminary effect of using robot at home. Data analysis SPSS Statistics 26 will be adopted for all analyses. Descriptive statistics, generalized estimating equations (GEE) models and a deductive content analysis approach will be used in data analysis. Significances of the study The study will add evidences in the field that social robot may be able to address some of the unmet needs of older people living at their own homes in the community, particularly relating to loneliness, enhancing the development of home-based care services for older adults.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

June 26, 2024

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Loneliness

    6-item Loneliness scale: It consists of two subscales: emotional loneliness (1-3 items) and social loneliness (4-6 items). There are negatively (1-3) and positively (4-6) worded items. On the negatively worded items, the neutral and positive answers are scored as "1". Therefore, on questions 1-3 score Yes=1, More or less=1, and No=0. On the positively worded items, the neutral and negative answers are scored as "1". Therefore, on questions 4-6, score Yes=0, More or less=1, and No=1. A score of 3 is the optimal cut point, with moderate or severe loneliness \[score of 3-6\]

    at baseline (day-1) and immediately post-intervention (week-6)

Secondary Outcomes (5)

  • Memory

    at baseline (day-1) and immediately post-intervention (week-6)

  • Emotion status

    at baseline (day-1) and immediately post-intervention (week-6)

  • Sense of coherence (SOC)

    at baseline (day-1) and immediately post-intervention (week-6)

  • Self-efficacy

    at baseline (day-1) and immediately post-intervention (week-6)

  • mutuality (if applicable)

    at baseline (day-1) and immediately post-intervention (week-6)

Study Arms (2)

A humanoid social robot

EXPERIMENTAL

Project team will set up a physical robot at their homes. Each participant will be given a protocol to engage with different features of the robot every day. Participants are asked to complete the assigned daily tasks at their own homes

Behavioral: A humanoid social robot

Control

NO INTERVENTION

Interventions

A humanoid social robot-mediated programme, including human-robot interactions, listening songs and daily news, doing physical activities and play memory games

A humanoid social robot

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ethnic Chinese aged 50 years and above;
  • Need home-based care from family caregiver, including spouses;
  • Live with at least one family caregiver at his/her own home (not in residential care homes) in Hong Kong;
  • Are able to communicate in Cantonese.

You may not qualify if:

  • With acute mental disorders or disabling diseases that may limit the practice of engaging with robot; and
  • have limited access to electricity and this makes them hard to use technology at home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Zhao IY, Leung AYM, Huang Y, Liu Y. A Social Robot in Home Care: Acceptability and Utility Among Community-Dwelling Older Adults. Innov Aging. 2025 Mar 8;9(5):igaf019. doi: 10.1093/geroni/igaf019. eCollection 2025.

MeSH Terms

Conditions

Cognitive DysfunctionDepression

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study will employ a two-arm pilot randomized control trial with qualitative interviews.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Head (Research)

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 5, 2024

Study Start

April 1, 2022

Primary Completion

March 6, 2024

Study Completion

September 27, 2024

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

individual participant data (IPD) will only be available per request and approve by the study team. The study team will publish the research findings without individual recognized data

Locations