Humanoid Robot vs Treatment as Usual for Loneliness

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05423899
• Other study ID #: 427283
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2022
• Source: Lady Davis Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Loneliness
• Quality of Life
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lady Davis Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Generalized Anxiety Disorder-7	Commonly-used validated scale to measure anxiety. Higher scores on this scale mean more symptoms of anxiety.	Baseline and Week 8
Other	EuroQoL-5 Dimensions	Commonly-used validated scale to measure quality of life. Higher scores on this scale mean a better quality of life.	Baseline and Week 8
Other	Change in acute healthcare utilization	Number of hospitalizations and emergency room visits between baseline and primary intervention endpoint.	Baseline and Week 8
Primary	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.	Baseline and Week 8
Secondary	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.	Baseline and Week 8
Secondary	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.	Baseline and Week 8