SimpleC Wellness Platform With Social Robot Interaction

Quality of Life Clinical Trial

Official title:

Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296239
• Other study ID #: 7645C
• Status: Completed
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: March 7, 2022

Study information

• Verified date: May 2022
• Source: SimpleC, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Engagement, Patient
• Mild Cognitive Impairment
• Mood
• Quality of Life

Intervention

Other:
• SimpleC Wellness Platform with Social Robot Interaction
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.

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia
United States	SimpleC, LLC	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
SimpleC, LLC	Advanced Medical Electronics, University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	3 weeks
Primary	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]	3 weeks
Secondary	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.	3 weeks
Secondary	Technology acceptance and adoption	[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.	3 weeks
Secondary	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	3 weeks
Secondary	Robot Social Attributes	[Interview] Social Assistive Robot social attributes are identified (e.g., friendliness, competency, etc)	3 weeks
Secondary	Usability and usefulness	Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]	3 weeks
Secondary	Conversation quality	[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.	3 weeks
Secondary	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.	3 weeks
Secondary	Requirements	Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]	3 weeks
Secondary	Affect	[Interview] Feelings of enjoyment, satisfaction, when using the technology	3 weeks
Secondary	Guilt Scale. A 4-point scale with higher score indicating higher guilt.	[Questionnaire] Family caregiver feelings of guilt.	3 weeks