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Completed

NCT Number: NCT06487611

The Presence of Humanoid Robot With Older Adults at Homes

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, 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. System usage will be measured at immediately post-intervention (week-6) for assessing the perceived usability of the robot.

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.

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Key information

Conditions

Loneliness Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Depression Mental Disorders Neurocognitive Disorders Self Efficacy Sense of Coherence

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

A humanoid social robot

Behavioral

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

Primary outcomes

  1. Loneliness

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

    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]

Secondary outcomes

  1. Memory

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

    5-items Abbreviated Memory Inventory for the Chinese (AMIC) scores range from 0-5 (1 point for each item; 0-best to 5-worse). An AMIC score ≥ 3 is predictive of MCI

  2. Emotion status

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

    • PHQ-2 includes 2 items. Not at all scores 0; Several days scores 1; More than half the days scores 2; and Nearly every day scores 3. Refuse to answer we put -99. A PHQ-2 score ranges from 0-6. A score of 3 is the optimal cut point, If the score is 3 or greater, major depressive disorder is likely.

  3. Sense of coherence (SOC)

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

    The SOC-13 scale has three components: Comprehensibility (items 2, 6, 8, 9, 11), Manageability (items 3, 5, 10, 13) and Meaningfulness (items 1, 4, 7, 12). This scale is rated on a 7-point likert scale, a total score can also be used and the coding for items 1, 2, 3, 7 and 10 should be reversed. SOC scores range from 13 to 91

  4. Self-efficacy

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

    The Chinese version of the General Self-Efficacy Scale is a reliable and valid scale that can be used with confidence in community Chinese soon-to-be-aged adults. The Scale consists of 10 items that measure a generalized sense of competence. All items are rated on a 4-point Likert scale ranging from 1='Not at all true' to 4='Exactly true'. The higher the score, the greater self-efficacy the respondents possess.

  5. System usability

    Time frame: Immediately post-intervention (week-6)

    The System Usability Scale (SUS) uses to measure perceived usability of the social robot in the intervention group. SUS has 10 items, with ratings on a 5-point Likert scale (1=Strongly Disagree to 5 = Strongly Agree). The overall SUS score ranges from 0 to 100, with higher score indicating higher usability.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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