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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05178992
• Other study ID #: 210386
• Secondary ID: R01AG062685
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 13, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: Vanderbilt University
• Contact: Kelley Colopietro, BS
• Phone: 4436176792
• Email: kelley.j.colopietro[@]vanderbilt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Behavioral:
• Socially Assistive Robot Activity
Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to Week 8
Secondary	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