MedPath

Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy

Phase 1
Recruiting
Conditions
Alzheimer Disease
Interventions
Behavioral: Socially Assistive Robot Activity
Registration Number
NCT05178992
Lead Sponsor
Vanderbilt University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Residing >3 months in long term care facility
  • Evidence of mild cognitive impairment (SAGE score 15-16), mild dementia (SAGE score <15, AD8<2, DSRD<19), or moderate dementia (SAGE <15, AD8>1, DSRD 19-36)
  • Symptoms of apathy (Score 30+ on AES-C)
Exclusion Criteria
  • Severe cognitive impairment
  • Physically unable to participate
  • Unable to provide assent
  • Uncorrected vision or hearing
  • Never spoke English
  • Unable to sit comfortably in chair
  • Acutely ill, terminally ill or unresponsive
  • Unable to be moved to activity location
  • Aggressive or combative

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Socially Assistive Robot ActivitySocially Assistive Robot ActivityParticipants 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.
Usual Activity ProgramSocially Assistive Robot ActivityParticipants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities.
Primary Outcome Measures
NameTimeMethod
Change in ApathyBaseline 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.

Secondary Outcome Measures
NameTimeMethod
Change in Animal Fluency TestBaseline 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.

Change in Trail Making Test (TMT)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.

Trial Locations

Locations (1)

Vanderbilt University

🇺🇸

Nashville, Tennessee, United States

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