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Study withdrawn to due issues with insurance of the robot.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humanoid Robot | Experimental |
| |
| Treatment as Usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grace Robot | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Health Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| EuroQoL-5 Dimensions | Commonly-used validated scale to measure quality of life. Higher scores on this scale mean a better quality of life. |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36339874 | Derived | 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. |
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No IPD sharing plan
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Treatment as Usual | Behavioral | 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. |
|
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 |
| Baseline and Week 8 |
| Change in acute healthcare utilization | Number of hospitalizations and emergency room visits between baseline and primary intervention endpoint. | Baseline and Week 8 |