Socially Assistive Robots for Interaction With Older Adults With Dementia

NCT04384978 | Completed Results DMC

• 2 other identifiers: 2020-001R44AG066439-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive/Memory Ability

  Participants will complete the Saint Louis University Mental Status (SLUMS) test, a screening method for Alzheimer's and other dementia. Scores range from 0 to 30. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.

  assessed at baseline (week 1), week 4, and 8. Week 8 reported.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.

Behavioral: Play Solitary Games Without a Social Robot

Active Group

EXPERIMENTAL

Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.

Behavioral: Play Serious Games with a Social Robot (Ryan)

Interventions

Play Serious Games with a Social Robot (Ryan) BEHAVIORAL

Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.

Active Group

Play Solitary Games Without a Social Robot BEHAVIORAL

Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Early Alzheimer's disease and related dementia diagnosed by a qualified provider
• Saint Louis University Mental Status (SLUMS) score between 10 and 25
• Resident of assisted living facility for at least one month prior and for the duration of the study
• Deemed conditioned enough to participate in physical activities after a wellness check
• Verbal skill to interact
• Participant or Legal decision

You may not qualify if:

• Aggressive behavior
• Diagnosed with severe dementia or memory loss
• Acute physical illness that impairs ability to participate
• Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment
• History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment
• Significant sensory impairment

Sponsors & Collaborators

• DreamFace Technologies, LLC: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Eaton Senior Communities

Lakewood, Colorado, 80226, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The study was conducted right after COVID-19 restrictions were lifted. The main limitation was that some potential subjects had medical constraints or concerns and did not want to participate. Additionally, poor internet connections in some senior care facilities limited the ability to converse with the robot.

Results Point of Contact

• Title: President and CEO
• Organization: DreamFace Technologies, LLC

mmahoor@dreamfacetech.com

7202015694

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder and CEO

Model Details: A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 12, 2020
• Study Start: January 12, 2020
• Primary Completion: March 6, 2022
• Study Completion: April 15, 2022
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)