LonelinessNCT06487611
The Presence of Humanoid Robot With Older Adults at Homes
A study testing A humanoid social robot in people with Loneliness and Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Cognitive Impairment, Depression
- What is being tested?
- A humanoid social robot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Loneliness, Cognitive Impairment, Depression, Self Efficacy, Sense of Coherence
- Being tested
- A humanoid social robot
- Medical subject headings
- Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A humanoid social robotBehavioural
A humanoid social robot-mediated programme, including human-robot interactions, listening songs and daily news, doing physical activities and play memory games
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: A humanoid social robot |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: at baseline (day-1) and immediately post-intervention (week-6)
Secondary outcomes (5)
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
Measured: at baseline (day-1) and immediately post-intervention (week-6)
Emotion status
- 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.
Measured: 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
Measured: 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.
Measured: at baseline (day-1) and immediately post-intervention (week-6)
System usability
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.
Measured: Immediately post-intervention (week-6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Apr 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will employ a two-arm pilot randomized control trial with qualitative interviews.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Angela Leung, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487611
- Sponsor's protocol ID
- P0041148
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 40386025
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Presence of Humanoid Robot With Older Adults at Homes
- ClinicalTrials.gov ID
- NCT06487611
- Acronym / sponsor ID
- P0041148
- Conditions
- Loneliness, Cognitive Impairment, Depression, Self Efficacy, Sense of Coherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will employ a two-arm pilot randomized control trial with qualitative interviews.
| Arm | Type | Receives |
|---|---|---|
| A humanoid social robot | Experimental | Behavioral: A humanoid social robotProject 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 |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A humanoid social robotA humanoid social robot-mediated programme, including human-robot interactions, listening songs and daily news, doing physical activities and play memory games | Behavioural | A humanoid social robot |
Primary outcome
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]
5 secondary outcomes
Memory
Time frame: at baseline (day-1) and immediately post-intervention (week-6)
Emotion status
Time frame: at baseline (day-1) and immediately post-intervention (week-6)
Sense of coherence (SOC)
Time frame: at baseline (day-1) and immediately post-intervention (week-6)
Self-efficacy
Time frame: at baseline (day-1) and immediately post-intervention (week-6)
System usability
Time frame: Immediately post-intervention (week-6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 40386025Zhao 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A humanoid social robot in people with Loneliness and Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: at baseline (day-1) and immediately post-intervention (week-6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.