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

NCT ID: NCT05178992

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2026-01-31

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Socially Assistive Robot Activity

Intervention Type BEHAVIORAL

Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.

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.

Group Type ACTIVE_COMPARATOR

Socially Assistive Robot Activity

Intervention Type BEHAVIORAL

Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Nilanjan Sarkar

David K. Wilson Professor of Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelley Colopietro, BS

Role: CONTACT

4436176792

Facility Contacts

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Nilanjan Sarkar, PhD

Role: primary

615-403-7440

Other Identifiers

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R01AG062685

Identifier Type: NIH

Identifier Source: secondary_id

View Link

210386

Identifier Type: -

Identifier Source: org_study_id

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