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Humanoid Robot vs Treatment as Usual for Loneliness

Humanoid Robot Intervention vs Treatment as Usual For Loneliness in Long-term Care Homes

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05423899
Enrollment
0
Registered
2022-06-21
Start date
2022-09-01
Completion date
2023-03-30
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Loneliness, Quality of Life, Stress

Keywords

Loneliness, Humanoid Robot, Depression, Long-term Care, Stress

Brief summary

The investigators are aiming to compare the effects of a humanoid robot intervention to treatment as usual, on loneliness and mental health outcomes in older adults living in long-term care, through an assessor-blinded randomized controlled trial.

Detailed description

Seventy-four (n=74) older adults experiencing loneliness in 3 long-term care homes will be randomized 1:1 to an 8-week, twice a week social intervention with the Grace humanoid robot vs. a treatment as usual active control. The investigators will assess change (baseline to week 8) in (1) loneliness (primary outcome), (2) depression severity and (3) stress (secondary outcomes), as well as (4) other exploratory outcomes : anxiety, quality of life and reduction in acute healthcare utilization. The investigators will also assess the feasibility and acceptability of the intervention using qualitative methods.

Interventions

BEHAVIORALGrace Robot

The Grace robot was designed by Awakening Health/Hanson Robotics for healthcare settings and to interact with the elderly and those isolated by the COVID-19 pandemic. Grace is a robot with a human-like appearance, which can move, actively listen, engage in conversation and react appropriately to human emotions. Intervention activities will mostly consist of active listening and general discussions about topics of interest (e.g. hobbies, music). The participant will also have the option of other types of interactions with the robot, including robot-led meditation, robot-led light exercise, listening to music and singing. Because loneliness is a subjective experience and does not have a standardized solution, this is a personalized intervention approach. We anticipate that each older adult participant will have different needs and wishes when interacting with the robot, which will allow for a more natural interaction with the robot.

BEHAVIORALTreatment as Usual

The treatment as usual active control group will not receive the robot intervention. The investIgators have deliberately chosen the participating long-term care (LTC) homes due to their high frequency of social interactions for their clients as part of their routine care (e.g. one-on-one and group activities, family interaction, exercise groups) compared to most LTC homes settings, making TAU an active control.

Sponsors

Lady Davis Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* living in a LTC home setting in Montreal * cognitively healthy, mild cognitive impairment (MCI) or mild dementia (MMSE score of \>20/clinical opinion of LTC homes staff members) * able to provide consent * loneliness UCLA-3 score of ≥ 6 or more (moderate-severe loneliness).

Exclusion criteria

* do not speak English * inability to provide consent * moderate to severe dementia (MMSE score \<18/diagnosis of moderate-severe dementia/clinical opinion of LTC homes staff members) * significant hearing loss * acutely unstable medical illnesses, including delirium, acute cerebrovascular/cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months * high suicide risk (e.g. active suicidal ideation and/or current/recent intent or plan).

Design outcomes

Primary

MeasureTime frameDescription
Change in the University of California Los Angeles 3-item Loneliness ScaleBaseline and Week 8Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.

Secondary

MeasureTime frameDescription
Change in the Perceived Stress ScaleBaseline and Week 814-item scale used to measure the degree to which life events are experienced and appraised as stressful. Higher scores on this scale mean higher stress levels.
Patient Health QuestionnaireBaseline and Week 89-item self-report questionnaire used to diagnose depression and assess symptom severity. Higher scores on this scale mean more symptoms of depression.

Other

MeasureTime frameDescription
Change in acute healthcare utilizationBaseline and Week 8Number of hospitalizations and emergency room visits between baseline and primary intervention endpoint.
Generalized Anxiety Disorder-7Baseline and Week 8Commonly-used validated scale to measure anxiety. Higher scores on this scale mean more symptoms of anxiety.
EuroQoL-5 DimensionsBaseline and Week 8Commonly-used validated scale to measure quality of life. Higher scores on this scale mean a better quality of life.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026