- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05296239
SimpleC Wellness Platform With Social Robot Interaction
Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Study Overview
Status
Conditions
Intervention / Treatment
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 (SARv) and physical social robot (SAR). 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- University of Georgia
-
Atlanta, Georgia, United States, 30060
- SimpleC, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SimpleC Wellness Platform with Social Robot Interaction
Three participant groups: Residents, family members, and staff
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facilitators to Successful Implementation
Time Frame: 3 weeks
|
[Interview] Identified factors that facilitate successful implementation (e.g., WiFi, environmental set up, user perceptions) as derived from analysis of interview.
A content analysis of the qualitative data was conducted.
This identified themes, such as usefulness or engagement.
We report the frequency of each theme mentioned during the interview.
|
3 weeks
|
|
Barriers to Successful Implementation
Time Frame: 3 weeks
|
[Interview] Identified factors that are barriers to implementation (e.g., WiFi, environmental set up, user perceptions) as derived from interview.
A content analysis of the qualitative data was conducted.
This identified themes, such as technology or hard to use.
We report the frequency of each theme mentioned during the interview.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
Time Frame: 3 weeks
|
[Questionnaires] Assessment of users' perceived ease of use and usefulness of using the technology. There are two sub-scales, with 6 questions each:
|
3 weeks
|
|
Technology Acceptance and Adoption
Time Frame: 3 weeks
|
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
A content analysis of the qualitative data was conducted.
This identified themes, such as music or trivia.
We report the frequency of each theme mentioned during the interview.
|
3 weeks
|
|
Robotic Social Attributes Scale (RoSAS): Family & Staff
Time Frame: 3 weeks
|
[Questionnaire] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort. An 18-item scale (1-7) with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort. There are three sub-scales, with 6 questions each:
|
3 weeks
|
|
Robotic Social Attributes Scale (RoSAS): Residents
Time Frame: 3 weeks
|
[Questionnaire] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort. An 18-item scale (1-3) with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort. Residents completed a simpler version of the RoSAS. There are three sub-scales, with 6 questions each:
|
3 weeks
|
|
Robot Social Attributes
Time Frame: 3 weeks
|
[Interview] Social Assistive Robot social attributes are identified (e.g., friendliness, competency, etc).
A content analysis of the qualitative data was conducted.
This identified themes, such as appearance or understanding.
We report the frequency of each theme mentioned during the interview.
|
3 weeks
|
|
Usability and Usefulness
Time Frame: 3 weeks
|
[Interview] Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of interview.
A content analysis of the qualitative data was conducted.
We report the frequency of the theme 'useful' and 'helpful' being mentioned during the interview.
|
3 weeks
|
|
Conversation Quality
Time Frame: 3 weeks
|
[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.
A content analysis of the qualitative data was conducted.
We report the frequency of the themes related to conversation quality mentioned during the interview, for example "understand" or "voice".
|
3 weeks
|
|
Value Proposition/Economic Impact
Time Frame: 3 weeks
|
[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.
A content analysis of the qualitative data was conducted.
We report the frequency of the use cases mentioned during the interview, for example "music" or "trivia" as high-value propositions.
|
3 weeks
|
|
Requirements
Time Frame: 3 weeks
|
[Interview + Observations] Identified requirements for design, training, and communication as derived from analysis of interview, observations.
A content analysis of the qualitative data was conducted.
We report the number of requirements mentioned & identified during the interview and observation, for example, enhancing audio features or updating the robot remotely.
|
3 weeks
|
|
Affect
Time Frame: 3 weeks
|
[Interview] Feelings of enjoyment, satisfaction, when using the technology.
A content analysis of the qualitative data was conducted.
We report the frequency of themes mentioned during the interview, for example "fun" or "engage".
|
3 weeks
|
|
Guilt Scale
Time Frame: 3 weeks
|
[Questionnaire] Guilt Scale.
A 3 question, 4-point scale (0 = not at all; 3 = almost unbearable), with a higher score indicating higher guilt for a composite score range of 0 to 9.
Only completed by one participant group: Family members
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Adams, PhD, SimpleC, LLC
- Principal Investigator: Jenay Beer, PhD, jenay.beer@uga.edu
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Neurocognitive Disorders
- Cognition Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Acceptance of Health Care
- Cognitive Dysfunction
- Disease
- Dementia
- Patient Participation
Other Study ID Numbers
- 7645C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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