Clinical trial NCT05296239: SimpleC Wellness Platform With Social Robot Interaction
Official title: Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Engagement, Patient
Mood
Quality of Life
Aging
Mild Cognitive Impairment
Cognitive Impairment
Dementia
Keywords: At risk
Diagnosis
Lead sponsor: SimpleC, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Georgia
name: Advanced Medical Electronics
First posted: 2022-03-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Facilitators to successful implementation
timeFrame: 3 weeks
measure: Barriers to successful implementation
timeFrame: 3 weeks
Secondary outcomes:
measure: Technology Acceptance Model Questionnaire. A 12-item scale with high scores indicating higher acceptance.
timeFrame: 3 weeks
measure: Technology acceptance and adoption
timeFrame: 3 weeks
measure: 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.
timeFrame: 3 weeks
measure: Robot Social Attributes
timeFrame: 3 weeks
measure: Usability and usefulness
timeFrame: 3 weeks
measure: Conversation quality
timeFrame: 3 weeks
measure: Value proposition/Economic Impact
timeFrame: 3 weeks
measure: Requirements
timeFrame: 3 weeks
measure: Affect
timeFrame: 3 weeks
measure: Guilt Scale. A 4-point scale with higher score indicating higher guilt.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
city: Atlanta
country: United States
facility: SimpleC, LLC
state: Georgia
Study officials:
affiliation: SimpleC, LLC
name: Anne Adams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: jenay.beer@uga.edu
name: Jenay Beer, PhD
role: PRINCIPAL_INVESTIGATOR
References: