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Clinical Trials/NCT05423899
NCT05423899
Withdrawn
Not Applicable

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

Lady Davis Institute0 sites74 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Loneliness
Sponsor
Lady Davis Institute
Enrollment
74
Primary Endpoint
Change in the University of California Los Angeles 3-item Loneliness Scale
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
March 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lady Davis Institute
Responsible Party
Principal Investigator
Principal Investigator

Soham Rej MD, MSc

Principal Investigator

Lady Davis Institute

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).

Outcomes

Primary Outcomes

Change in the University of California Los Angeles 3-item Loneliness Scale

Time Frame: Baseline and Week 8

Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.

Secondary Outcomes

  • Change in the Perceived Stress Scale(Baseline and Week 8)
  • Patient Health Questionnaire(Baseline and Week 8)

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