Vanderbilt University
Nashville, Tennessee, 37212-2010, United States
NCT Number: NCT05178992
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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Notify Me60 year and older
All sexes
Interventional
Phase 1 / Phase 2
Nashville, Tennessee, 37212-2010, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.
Time frame: Baseline to Week 8
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.
Time frame: Baseline to Week 8
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.
Time frame: Baseline to Week 8
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.
Vanderbilt University
Other
Impact of a Novel Socially Assistive Robotic Architecture on Engaging Older Adults With Mild Cognitive Impairment, Alzheimer's Disease and Related Dementia in Long Term Care Settings
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