The Presence of Humanoid Robot With Older Adults at Homes
NCT Number: NCT06487611
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Loneliness|Cognitive Impairment|Depression|Self Efficacy|Sense of Coherence
Interventions: BEHAVIORAL: A humanoid social robot
Sponsor: The Hong Kong Polytechnic University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-04-01
Completion Date: 2024-09-27
Locations: The Hong Kong Polytechnic University, Hong Kong, Hong Kong

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.

Primary Outcome Measures: 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 Outcome Measures: Memory, 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, at baseline (day-1) and immediately post-intervention (week-6)|Emotion status, 4. 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., at baseline (day-1) and immediately post-intervention (week-6)|Sense of coherence (SOC), 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, at baseline (day-1) and immediately post-intervention (week-6)|Self-efficacy, 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., at baseline (day-1) and immediately post-intervention (week-6)|mutuality (if applicable), Each item is scored on a 5-point Likert-type scale from 0 ( not at all ) to 4 ( a great deal ). The total scale score, a mean of all item scores, ranges from 0 to 4: higher scores means greater mutuality., at baseline (day-1) and immediately post-intervention (week-6)