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Clinical Trials/NCT05296239
NCT05296239
Completed
N/A

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

SimpleC, LLC2 sites in 1 country26 target enrollmentFebruary 3, 2022

Overview

Phase
N/A
Intervention
SimpleC Wellness Platform with Social Robot Interaction
Conditions
Engagement, Patient
Sponsor
SimpleC, LLC
Enrollment
26
Locations
2
Primary Endpoint
Facilitators to Successful Implementation
Status
Completed
Last Updated
last month

Overview

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 (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.

Registry
clinicaltrials.gov
Start Date
February 3, 2022
End Date
March 7, 2022
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
SimpleC, LLC
Responsible Party
Sponsor

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

Arms & Interventions

SimpleC Wellness Platform with Social Robot Interaction

Three participant groups: Residents, family members, and staff

Intervention: SimpleC Wellness Platform with Social Robot Interaction

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Affect(3 weeks)
  • Robot Social Attributes(3 weeks)
  • Requirements(3 weeks)
  • Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.(3 weeks)
  • Technology Acceptance and Adoption(3 weeks)
  • Guilt Scale(3 weeks)
  • Robotic Social Attributes Scale (RoSAS): Family & Staff(3 weeks)
  • Robotic Social Attributes Scale (RoSAS): Residents(3 weeks)
  • Usability and Usefulness(3 weeks)
  • Conversation Quality(3 weeks)
  • Value Proposition/Economic Impact(3 weeks)

Study Sites (2)

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