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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG062685 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. Earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. First, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. Second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. Researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Socially Assistive Robot Activity | Experimental | Participants will attend two sessions per week and interact with the robot. Four weeks with a humanoid robot and four weeks with a dog robot. Participants can continue to join other activities held within the facility. |
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| Usual Activity Program | Active Comparator | Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socially Assistive Robot Activity | Behavioral | Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apathy | Apathy Evaluation Scale - Clinician (AES-C) will be used to assess changes in composite apathy score from baseline, Week 4, and Week 8. The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate greater apathy. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Trail Making Test (TMT) | The TMT is a well established test of executive function and has two forms. TMT-A consists of a series of numbers in circles displayed randomly on a page; the person links the numbers in sequence. TMT-B consists of numbers (1 to 13) and letters (A to L) inside circles randomly placed on a page; the person alternates in connecting ascending numbers with ascending letters. TMT is scored by time in seconds to complete, up to 5 minutes. TMT-A normal time is 29 seconds and deficient score is >78 seconds. TMT-B average score is 75 seconds and deficient score > 273 seconds. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37212-2010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41330571 | Derived | Ghosh R, Khan N, Migovich M, Tate JA, Maxwell CA, Newhouse PA, Scharre DW, Tan A, Mion LC, Sarkar N. Engaging Older Adults and Staff in the Co-Design and Evaluation of Socially Assistive Robot and Virtual Reality Activities for Long-Term Care: User-Centered Study. JMIR Aging. 2025 Dec 2;8:e75288. doi: 10.2196/75288. | |
| 40482961 | Derived | Tate JA, Mion LC, Migovich M, Ghosh R, Khan N, Kilpatrick A, Scharre DW, Newhouse PA, Maxwell CA, Tan A, Sarkar N. A multi-site randomized clinical trial of socially assistive robots on engaging older adults with cognitive impairment residing in long-term care settings: A protocol paper. Contemp Clin Trials. 2025 Aug;155:107980. doi: 10.1016/j.cct.2025.107980. Epub 2025 Jun 6. |
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All IPD that are de-identified and have been used in publications.
12 months after publications
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2023 | May 6, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants will be randomized to either Usual Activity Program or Usual Activity Program + Robot Activity within each long term care facility. At each site, the order of the robot type (humanoid or dog) will be randomized. Each participant will participate in two sessions/week for 8 weeks (4 weeks with humanoid robot, 4 weeks with dog robot).
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Trained research assistants separate from other research personnel will collect outcomes; these research personnel will be blinded to the hypotheses and group assignments.
| Baseline to Week 8 |
| Change in Animal Fluency Test | Verbal fluency tests require verbal ability and executive control processes; the Animal Naming test requires naming 15 animals in 1 minute; thus, less than 15 animals named in 1 minute is considered a deficient score. | Baseline to Week 8 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |