SimpleC Wellness Platform With Social Robot Interaction

Sponsor
SimpleC, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT05296239
Collaborator
University of Georgia (Other), Advanced Medical Electronics (Other)
26
2
1
1.1
13
12.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SimpleC Wellness Platform with Social Robot Interaction
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Actual Study Start Date :
Feb 3, 2022
Actual Primary Completion Date :
Mar 7, 2022
Actual Study Completion Date :
Mar 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SimpleC Wellness Platform with Social Robot Interaction

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.

Outcome Measures

Primary Outcome Measures

  1. Facilitators to successful implementation [3 weeks]

    Identified factors that facilitate successful implementation (e.g., WiFi, environmental set up, user perceptions) as derived from analysis of: [interview, observational notes, usage data]

  2. Barriers to successful implementation [3 weeks]

    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

  1. Technology Acceptance Model Questionnaire. A 12-item scale with high scores indicating higher acceptance. [3 weeks]

    [Questionnaires] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.

  2. Technology acceptance and adoption [3 weeks]

    [Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.

  3. 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. [3 weeks]

    [Questionnaire] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort

  4. Robot Social Attributes [3 weeks]

    [Interview] Social Assistive Robot social attributes are identified (e.g., friendliness, competency, etc)

  5. Usability and usefulness [3 weeks]

    Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]

  6. Conversation quality [3 weeks]

    [Interview] User perceptions on the usefulness and ease of use in conversing with the technology.

  7. Value proposition/Economic Impact [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.

  8. Requirements [3 weeks]

    Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]

  9. Affect [3 weeks]

    [Interview] Feelings of enjoyment, satisfaction, when using the technology

  10. Guilt Scale. A 4-point scale with higher score indicating higher guilt. [3 weeks]

    [Questionnaire] Family caregiver feelings of guilt.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Georgia Athens Georgia United States 30602
2 SimpleC, LLC Atlanta Georgia United States 30060

Sponsors and Collaborators

  • SimpleC, LLC
  • University of Georgia
  • Advanced Medical Electronics

Investigators

  • Principal Investigator: Anne Adams, PhD, SimpleC, LLC
  • Principal Investigator: Jenay Beer, PhD, jenay.beer@uga.edu

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SimpleC, LLC
ClinicalTrials.gov Identifier:
NCT05296239
Other Study ID Numbers:
  • 7645C
First Posted:
Mar 25, 2022
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SimpleC, LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022