Humanoid Robot vs Treatment as Usual for Loneliness

Sponsor

Lady Davis Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05423899

Collaborator

(none)

Enrollment

Arms

12.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Loneliness Depression Stress Anxiety Quality of Life	Behavioral: Grace Robot Behavioral: Treatment as Usual	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Humanoid Robot	Behavioral: Grace 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.
Active Comparator: Treatment as Usual	Behavioral: Treatment 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.

Arm

Intervention/Treatment

Experimental: Humanoid Robot

Behavioral: Grace 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.

Active Comparator: Treatment as Usual

Behavioral: Treatment 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.

Outcome Measures

Primary Outcome Measures

Change in the University of California Los Angeles 3-item Loneliness Scale [Baseline and Week 8]
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 [Baseline and Week 8]
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 [Baseline and Week 8]
9-item self-report questionnaire used to diagnose depression and assess symptom severity. Higher scores on this scale mean more symptoms of depression.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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).