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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
Lady Davis Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Loneliness focused on measuring Loneliness, Humanoid Robot, Depression, Long-term Care, Stress

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 1, 2022
    Last Updated
    June 15, 2022
    Sponsor
    Lady Davis Institute
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    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

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