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Clinical Trials/NCT05178992
NCT05178992
Completed
Phase 1

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

Vanderbilt University1 site in 1 country142 target enrollmentFebruary 7, 2023

Overview

Phase
Phase 1
Intervention
Socially Assistive Robot Activity
Conditions
Alzheimer Disease
Sponsor
Vanderbilt University
Enrollment
142
Locations
1
Primary Endpoint
Change in Apathy
Status
Completed
Last Updated
5 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 7, 2023
End Date
January 31, 2026
Last Updated
5 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nilanjan Sarkar

David K. Wilson Professor of Engineering

Vanderbilt University

Eligibility Criteria

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

Arms & Interventions

Socially Assistive Robot Activity

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.

Intervention: Socially Assistive Robot Activity

Usual Activity Program

Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities.

Intervention: Socially Assistive Robot Activity

Outcomes

Primary Outcomes

Change in Apathy

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.

Secondary Outcomes

  • Change in Animal Fluency Test(Baseline to Week 8)
  • Change in Trail Making Test (TMT)(Baseline to Week 8)

Study Sites (1)

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