Humanoid Robot vs Treatment as Usual for Loneliness

Lady Davis Institute

Status: Withdrawn

Conditions: Quality of Life; Loneliness; Depression; Anxiety; Stress

Treatments: Behavioral: Grace Robot; Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05423899

427283

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Humanoid Robot

Experimental group

Treatment:

Behavioral: Grace Robot

Treatment as Usual

Active Comparator group

Treatment:

Behavioral: Treatment as Usual