Back to resultsSocially Assistive Robots for Interaction With Older Adults With Dementia
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Play Serious Games with a Social Robot (Ryan)
Play Solitary Games Without a Social Robot
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria:
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
Sites / Locations
- Eaton Senior CommunitiesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Active Group
Arm Description
Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.
Outcomes
Primary Outcome Measures
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.
The measurement will be conducted three times over 1 year duration of the study (baseline, 6 months, and 1 year).
Secondary Outcome Measures
Full Information
NCT ID
NCT04384978
First Posted
May 5, 2020
Last Updated
October 28, 2021
Sponsor
DreamFace Technologies, LLC
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04384978
Brief Title
Socially Assistive Robots for Interaction With Older Adults With Dementia
Official Title
Development of Serious Games and Physical Activities Instructed by a Social Robot for Improving the Well-being of Elderly Individuals With Alzheimer's Disease and Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
March 6, 2022 (Anticipated)
Study Completion Date
April 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DreamFace Technologies, LLC
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control Group: Group 2 users will play solitary games (word puzzles) and activities but will have no interaction with Ryan.
Arm Title
Active Group
Arm Type
Experimental
Arm Description
Active Group: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day.
Intervention Type
Behavioral
Intervention Name(s)
Play Serious Games with a Social Robot (Ryan)
Intervention Description
Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.
Intervention Type
Behavioral
Intervention Name(s)
Play Solitary Games Without a Social Robot
Intervention Description
Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.
Primary Outcome Measure Information:
Title
change in cognitive/memory ability
Description
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.
The measurement will be conducted three times over 1 year duration of the study (baseline, 6 months, and 1 year).
Time Frame
baseline, 6 months, and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Schoeder
Phone
303-937-3184
Email
sschoeder@eatonsenior.org
Facility Information:
Facility Name
Eaton Senior Communities
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Schoeder
Phone
303-937-3184
Email
sschoeder@eatonsenior.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Socially Assistive Robots for Interaction With Older Adults With Dementia
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