Purpose

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

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
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).
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37212-2010
Contact:
Nilanjan Sarkar, PhD
615-403-7440
nilanjan.sarkar@vanderbilt.edu

More Details

Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

Kelley Colopietro, BS
4436176792
kelley.j.colopietro@vanderbilt.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.