Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy
Primary Purpose
Alzheimer Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Socially Assistive Robot Activity
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Apathy, Robotics, Virtual Reality
Eligibility Criteria
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
Sites / Locations
- Vanderbilt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Socially Assistive Robot Activity
Usual Activity Program
Arm Description
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.
Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05178992
First Posted
December 15, 2021
Last Updated
February 5, 2023
Sponsor
Vanderbilt University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05178992
Brief Title
Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Apathy, Robotics, Virtual Reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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).
Masking
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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Socially Assistive Robot Activity
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Activity Program
Arm Type
Active Comparator
Arm Description
Participants will attend at least two sessions per week at activities held within the facility. They will not be exposed to the robot activities.
Intervention Type
Behavioral
Intervention Name(s)
Socially Assistive Robot Activity
Intervention Description
Participants will attend two weekly sessions with robot activities. Each session will last 30 minutes. Participants will attend robot sessions for 8 weeks.
Primary Outcome Measure Information:
Title
Change in Apathy
Description
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.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change in Trail Making Test (TMT)
Description
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.
Time Frame
Baseline to Week 8
Title
Change in Animal Fluency Test
Description
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.
Time Frame
Baseline to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelley Colopietro, BS
Phone
6159360461
Email
kelley.j.colopietro@vanderbilt.edu
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilanjan Sarkar, PhD
Phone
615-403-7440
Email
nilanjan.sarkar@vanderbilt.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that are de-identified and have been used in publications.
IPD Sharing Time Frame
12 months after publications
Learn more about this trial
Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy
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