Clinical trial NCT05423899: Humanoid Robot vs Treatment as Usual for Loneliness
Official title: Humanoid Robot Intervention vs Treatment as Usual For Loneliness in Long-term Care Homes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Loneliness
Depression
Stress
Anxiety
Quality of Life
Keywords: Loneliness
Humanoid Robot
Depression
Long-term Care
Stress
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in the University of California Los Angeles 3-item Loneliness Scale
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in the Perceived Stress Scale
timeFrame: Baseline and Week 8
measure: Patient Health Questionnaire
timeFrame: Baseline and Week 8
Other outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: Baseline and Week 8
measure: EuroQoL-5 Dimensions
timeFrame: Baseline and Week 8
measure: Change in acute healthcare utilization
timeFrame: Baseline and Week 8
Locations:
Study officials:
References:
citation: Lavin P, Lesage M, Monroe E, Kanevsky M, Gruber J, Cinalioglu K, Rej S, Sekhon H. Humanoid robot intervention vs. treatment as usual for loneliness in long-term care homes: Study protocol for a pilot randomized controlled trial. Front Psychiatry. 2022 Oct 21;13:1003881. doi: 10.3389/fpsyt.2022.1003881. eCollection 2022.