Clinical trial NCT06487611: The Presence of Humanoid Robot With Older Adults at Homes
Official title: The Presence of Humanoid Robot With Older Adults at Homes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Loneliness
Cognitive Impairment
Depression
Self Efficacy
Sense of Coherence
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will employ a two-arm pilot randomized control trial with qualitative interviews.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Loneliness
timeFrame: at baseline (day-1) and immediately post-intervention (week-6)
Secondary outcomes:
measure: Memory
timeFrame: at baseline (day-1) and immediately post-intervention (week-6)
measure: Emotion status
timeFrame: at baseline (day-1) and immediately post-intervention (week-6)
measure: Sense of coherence (SOC)
timeFrame: at baseline (day-1) and immediately post-intervention (week-6)
measure: Self-efficacy
timeFrame: at baseline (day-1) and immediately post-intervention (week-6)
measure: mutuality (if applicable)
timeFrame: at baseline (day-1) and immediately post-intervention (week-6)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: