SimpleC Wellness Platform With Social Robot Interaction
Primary Purpose
Engagement, Patient, Mood, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SimpleC Wellness Platform with Social Robot Interaction
Sponsored by
About this trial
This is an interventional other trial for Engagement, Patient focused on measuring At risk, Diagnosis
Eligibility Criteria
Inclusion Criteria:
- All: Fluent in English
- Resident: 50 years and older
- Resident: lives in Assisted Living Community
- Resident: MMSE score of 13 or higher
- Family member: 18 years and older
- Family member: family or friend of resident
- Family member: no diagnosis of dementia or related disorder
- Staff: 18 years and older
- Staff: works for the Senior Housing Community
Exclusion Criteria:
- All: pregnant
- Resident: Expecting to move during the study
- Resident: Both legally deaf and blind
Sites / Locations
- University of Georgia
- SimpleC, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SimpleC Wellness Platform with Social Robot Interaction
Arm Description
Outcomes
Primary Outcome Measures
Facilitators to successful implementation
Identified factors that facilitate successful implementation (e.g., WiFi, environmental set up, user perceptions) as derived from analysis of: [interview, observational notes, usage data]
Barriers to successful implementation
Identified factors that are barriers to implementation (e.g., WiFi, environmental set up, user perceptions) as derived from: [interview, observational notes, usage data]
Secondary Outcome Measures
Technology Acceptance Model Questionnaire. A 12-item scale with high scores indicating higher acceptance.
[Questionnaires] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.
Technology acceptance and adoption
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Robotic Social Attributes Scale (RoSAS). An 18-item scale with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort.
[Questionnaire] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort
Robot Social Attributes
[Interview] Social Assistive Robot social attributes are identified (e.g., friendliness, competency, etc)
Usability and usefulness
Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]
Conversation quality
[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.
Value proposition/Economic Impact
[Interview] Discussions with facility staff and key decision makers to understand the value of the technology in providing social interaction and reminders to their residents.
Requirements
Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]
Affect
[Interview] Feelings of enjoyment, satisfaction, when using the technology
Guilt Scale. A 4-point scale with higher score indicating higher guilt.
[Questionnaire] Family caregiver feelings of guilt.
Full Information
NCT ID
NCT05296239
First Posted
February 23, 2022
Last Updated
May 3, 2022
Sponsor
SimpleC, LLC
Collaborators
University of Georgia, Advanced Medical Electronics
1. Study Identification
Unique Protocol Identification Number
NCT05296239
Brief Title
SimpleC Wellness Platform With Social Robot Interaction
Official Title
Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
March 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SimpleC, LLC
Collaborators
University of Georgia, Advanced Medical Electronics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This implementation study will be conducted to test a Socially-Assistive Robot (SAR) system for residents in an Assisted Living environment. The goal of the SAR system is to enhance social engagement and connectedness. The system engages residents via robot-facilitated activities such as trivia and reminder and is integrated with the SimpleC Wellness Platform.
Detailed Description
This is a 3-week mixed-method study to assess the installation procedure, assess user first impressions, develop training, assess user materials, and identify any barriers and concerns during implementation. New features and design will be validated.
Research questions include:
How should the SAR system be introduced to the users and their environment?
What are facilitators and barriers to implementation?
Will users accept the SAR system in their environment?
What are facilitators and barriers to SAR system acceptance?
What are the desired parameters that the SAR system should have?
What social behaviors do users expect?
What tasks would be acceptable that the SAR system tablet do?
How should the SAR system's perception, competence, and awareness be presented to users?
What is most valuable to users and why?
If the answer depends, then what does it depend on (user, task, environment)?
Sample: Thirty individuals will participate: 10 residents, 10 family, and 10 staff. Enrollment will stop when reaching saturation.
Procedure: The research will follow established procedures for recruitment, screening, and assessment. Participants will provide informed consent, which will be followed by a baseline assessment. Participants will be screened to ascertain inclusion and exclusion criteria. Residents and Senior Housing Community will receive the new SAR system, which includes a virtual robot and physical social robot. At the beginning of the study, enrolled residents will receive a tablet with a personalized profile, wellness programs, and virtual robot using the standard SimpleC enrollment process. Installation will be followed by training. Residents and family will be invited to personalize residents' profile and programming. One social robot will be implement for the whole community. Participants will engage with the SAR system as they are willing. All staff, residents, and family will be invited to use the SAR system, independent of study participation status. At the end of the study, assessments will be administered, which is followed by a brief interview.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Engagement, Patient, Mood, Quality of Life, Aging, Mild Cognitive Impairment, Cognitive Impairment, Dementia
Keywords
At risk, Diagnosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SimpleC Wellness Platform with Social Robot Interaction
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
SimpleC Wellness Platform with Social Robot Interaction
Intervention Description
Once respondents enroll, they will receive the SimpleC Wellness Platform, including introduction training on the SAR system. During the study period, participants and others will receive instructions for the SAR system and use it as part of scheduled interactions, which includes interactions as part of the general schedule. In the third week, the social robot will be installed, and staff trained in group sessions as available. Participants may use the full SAR system as they are willing.
Interactions specific to the virtual and physical robot include notifications to join activities as per community schedule as well as trivia.
Primary Outcome Measure Information:
Title
Facilitators to successful implementation
Description
Identified factors that facilitate successful implementation (e.g., WiFi, environmental set up, user perceptions) as derived from analysis of: [interview, observational notes, usage data]
Time Frame
3 weeks
Title
Barriers to successful implementation
Description
Identified factors that are barriers to implementation (e.g., WiFi, environmental set up, user perceptions) as derived from: [interview, observational notes, usage data]
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Technology Acceptance Model Questionnaire. A 12-item scale with high scores indicating higher acceptance.
Description
[Questionnaires] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.
Time Frame
3 weeks
Title
Technology acceptance and adoption
Description
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Time Frame
3 weeks
Title
Robotic Social Attributes Scale (RoSAS). An 18-item scale with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort.
Description
[Questionnaire] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort
Time Frame
3 weeks
Title
Robot Social Attributes
Description
[Interview] Social Assistive Robot social attributes are identified (e.g., friendliness, competency, etc)
Time Frame
3 weeks
Title
Usability and usefulness
Description
Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]
Time Frame
3 weeks
Title
Conversation quality
Description
[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.
Time Frame
3 weeks
Title
Value proposition/Economic Impact
Description
[Interview] Discussions with facility staff and key decision makers to understand the value of the technology in providing social interaction and reminders to their residents.
Time Frame
3 weeks
Title
Requirements
Description
Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]
Time Frame
3 weeks
Title
Affect
Description
[Interview] Feelings of enjoyment, satisfaction, when using the technology
Time Frame
3 weeks
Title
Guilt Scale. A 4-point scale with higher score indicating higher guilt.
Description
[Questionnaire] Family caregiver feelings of guilt.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All: Fluent in English
Resident: 50 years and older
Resident: lives in Assisted Living Community
Resident: MMSE score of 13 or higher
Family member: 18 years and older
Family member: family or friend of resident
Family member: no diagnosis of dementia or related disorder
Staff: 18 years and older
Staff: works for the Senior Housing Community
Exclusion Criteria:
All: pregnant
Resident: Expecting to move during the study
Resident: Both legally deaf and blind
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Adams, PhD
Organizational Affiliation
SimpleC, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jenay Beer, PhD
Organizational Affiliation
jenay.beer@uga.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
Facility Name
SimpleC, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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SimpleC Wellness Platform With Social Robot Interaction
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