SimpleC Wellness Platform With Social Robot Interaction

NCT ID: NCT05296239

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2022-03-07

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SimpleC Wellness Platform with Social Robot Interaction

Group Type: EXPERIMENTAL

SimpleC Wellness Platform with Social Robot Interaction

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Georgia

OTHER

Sponsor Role: collaborator

Advanced Medical Electronics

OTHER

Sponsor Role: collaborator

SimpleC, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

SimpleC, LLC

Jenay Beer, PhD

Role: PRINCIPAL_INVESTIGATOR

jenay.beer@uga.edu

Locations

University of Georgia

Athens, Georgia, United States

SimpleC, LLC

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

7645C

Identifier Type: -

Identifier Source: org_study_id