Robot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)

November 1, 2022 updated by: Jenay M. Beer, University of Georgia

Robot-Assisted Cognitive Training for Socially Isolated Older Adults With Mild Cognitive Impairment

This study will use a socially assistive robot to deliver cognitive training in the form of a music (piano) learning intervention to socially isolated older adults with mild cognitive impairment.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

Cognitive training has been shown in past research to improve cognitive function in older adults with and without mild cognitive impairment. Music learning has been previously shown to be a particularly effective form of cognitive training: in addition to the cognitive demands of learning notation, hand positioning, coordination and timing, those who engage in music learning also benefit from emotional connection to the music and social engagement with a music teacher.

Not all older adults are able to access music lessons. Older adults who are homebound, live in rural areas and do not have access to reliable transportation (or a monthly income with sufficient funds for recurring payments for lessons) are unlikely to be able to access these benefits. Socially assistive robots that can deliver both education and companionship on an ongoing basis within the home environment may be a viable solution to these limitations.

The purpose of this study is to deliver cognitive training in the form of a music (piano) learning intervention to older adults who are socially isolated, and who may be able to benefit from the cognitive training aspects of the intervention. A socially assistive robot will deliver the intervention.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Athens, Georgia, United States, 30602
        • University of Georgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be able to speak, read and write in English with a high degree of fluency
  • Cumulative music learning experience < 3 years
  • Able to sit upright for two hours at a time
  • Able to see images on a screen at a distance of approximately 20 inches
  • Must have independent transportation to and from the Institute of Gerontology, weekly, for 27 weeks
  • No hearing impairment beyond what is correctable via hearing aid
  • Must have a safe location in the home to store and use an 88-key keyboard + stand and piano bench
  • No more than mildly cognitively impaired: global deterioration scale no higher than 2-3; Clinical Dementia Rating Scale no higher than 0.5 (sum of boxes)
  • Must have a close companion, family member or loved one who can attend the first and last visit
  • Must be capable of providing informed consent (based on responses to questions on study purpose, tasks, benefits, incentives and risks).
  • Must have a computer or tablet that is connected to broadband internet, to be used three times over the course of the study
  • Must have access to an e-mail account that can be checked three times during the study

Exclusion criteria:

  • No previous diagnosis of Alzheimer's disease or related dementias
  • No condition that limits movement of the hands or fingers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Socially Assistive Robot Intervention
Piano training intervention led by a semi-autonomous socially assistive robot
Cognitive training via music learning
ACTIVE_COMPARATOR: Content Only Intervention
Piano training intervention using the same curriculum displayed on a computer monitor, without the socially assistive robot tutor.
Cognitive training via music learning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Memory Test
Time Frame: 6-months
Correct hits + Correct passes + Correct hits after 30-minute delay + Correct passes after 30-minute delay; higher score is better; items remembered from a word list that also contains distractors
6-months
Visual Memory Test
Time Frame: 6-months
Correct hits + Correct passes + Correct hits after 30-minute delay + Correct passes after 30-minute delay; higher score is better; images remembered from an image list that also contains distractors
6-months
Non-Verbal Reasoning Test
Time Frame: 6-months
correct responses - commission errors; higher score is better
6-months
Shifting Attention Test
Time Frame: 6-months
correct responses - errors; higher is better
6-months
Stroop Test
Time Frame: 6-months
[Simple RT < (Complex RT Correct *0.1)+Complex RT Correct] AND [Complex RT Correct < ( Stroop RT Correct *0.1)+Stroop RT Correct] AND (Complex Correct > Complex Errors) AND (Stroop Correct > Stroop Errors)
6-months
Continuous Performance Test
Time Frame: 6-months
CPT Correct Responses >= 30 AND CPT Correct Responses > CPT Commission Errors
6-months
Symbol Digit Coding Test
Time Frame: 6-months
SDC Correct Responses >= 20 AND Correct Responses > Errors
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technology Acceptance - TAM3
Time Frame: 6-months
higher sore = greater acceptance
6-months
DeJong Loneliness Scale
Time Frame: 6-months
Higher scores indicate more severe loneliness
6-months
NASA TLX
Time Frame: 6-months
Measures workload; higher score = more work
6-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global deterioration scale
Time Frame: 6-months
Staging of cognitive impairment based on a structured clinical interview; higher score = more severe impairment
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jenay Beer, Ph.D., The University of Georgia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 7, 2021

Primary Completion (ANTICIPATED)

August 31, 2023

Study Completion (ANTICIPATED)

August 31, 2023

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (ACTUAL)

August 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with researchers outside of the study site.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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