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

NCT05178992 | Completed Phase 1 DMC

• 2 other identifiers: 210386R01AG062685
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Apathy; Robotics; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Trail Making Test (TMT)

  Baseline to Week 8

• Change in Animal Fluency Test

  Baseline to Week 8

Study Arms (2)

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.

Behavioral: Socially Assistive Robot Activity

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.

Behavioral: Socially Assistive Robot Activity

Interventions

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.

Socially Assistive Robot Activity; Usual Activity Program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212-2010, United States

Location

Related Publications (1)

• 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.

  PMID: 41330571 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Lethargy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trained research assistants separate from other research personnel will collect outcomes; these research personnel will be blinded to the hypotheses and group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David K. Wilson Professor of Engineering

Model Details: 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).

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 5, 2022
• Study Start: February 7, 2023
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 12 months after publications

Locations

US (1)