Humanoid Robot vs Treatment as Usual for Loneliness
Primary Purpose
Loneliness, Depression, Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Grace Robot
Treatment as Usual
Sponsored by

About this trial
This is an interventional treatment trial for Loneliness focused on measuring Loneliness, Humanoid Robot, Depression, Long-term Care, Stress
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Humanoid Robot
Treatment as Usual
Arm Description
Outcomes
Primary Outcome Measures
Change in the University of California Los Angeles 3-item Loneliness Scale
Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.
Secondary Outcome Measures
Change in the Perceived Stress Scale
14-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 Questionnaire
9-item self-report questionnaire used to diagnose depression and assess symptom severity. Higher scores on this scale mean more symptoms of depression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05423899
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loneliness, Depression, Stress, Anxiety, Quality of Life
Keywords
Loneliness, Humanoid Robot, Depression, Long-term Care, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Humanoid Robot
Arm Type
Experimental
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Grace Robot
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the University of California Los Angeles 3-item Loneliness Scale
Description
Commonly-used validated scale to screen for loneliness. Higher scores on this scale mean higher levels of loneliness.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change in the Perceived Stress Scale
Description
14-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.
Time Frame
Baseline and Week 8
Title
Patient Health Questionnaire
Description
9-item self-report questionnaire used to diagnose depression and assess symptom severity. Higher scores on this scale mean more symptoms of depression.
Time Frame
Baseline and Week 8
Other Pre-specified Outcome Measures:
Title
Generalized Anxiety Disorder-7
Description
Commonly-used validated scale to measure anxiety. Higher scores on this scale mean more symptoms of anxiety.
Time Frame
Baseline and Week 8
Title
EuroQoL-5 Dimensions
Description
Commonly-used validated scale to measure quality of life. Higher scores on this scale mean a better quality of life.
Time Frame
Baseline and Week 8
Title
Change in acute healthcare utilization
Description
Number of hospitalizations and emergency room visits between baseline and primary intervention endpoint.
Time Frame
Baseline and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD sharing plan
Citations:
PubMed Identifier
36339874
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.
Results Reference
derived
Learn more about this trial
Humanoid Robot vs Treatment as Usual for Loneliness
We'll reach out to this number within 24 hrs