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

Sponsor

Vanderbilt University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05178992

Collaborator

National Institute on Aging (NIA) (NIH)

200

Enrollment

Location

Arms

45.6

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Behavioral: Socially Assistive Robot Activity	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

Single (Outcomes Assessor)

Masking Description:

Trained research assistants separate from other research personnel will collect outcomes; these research personnel will be blinded to the hypotheses and group assignments.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 13, 2021

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Change in Apathy [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 Outcome Measures

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.
Change in Animal Fluency Test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37212-2010

Sponsors and Collaborators

Vanderbilt University
National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nilanjan Sarkar, David K. Wilson Professor of Engineering, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT05178992

Other Study ID Numbers:

210386
R01AG062685

First Posted:

Jan 5, 2022

Last Update Posted:

Jan 5, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nilanjan Sarkar, David K. Wilson Professor of Engineering, Vanderbilt University

Apathy

Robotics

Virtual Reality

Additional relevant MeSH terms:

Alzheimer Disease

Cognitive Dysfunction

Study Results

No Results Posted as of Jan 5, 2022