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SimpleC Wellness Platform With Social Robot Interaction

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05296239
Enrollment
26
Registered
2022-03-25
Start date
2022-02-03
Completion date
2022-03-07
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

At risk, Diagnosis

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.

Interventions

OTHERSimpleC 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.

Sponsors

SimpleC, LLC
Lead SponsorINDUSTRY
University of Georgia
CollaboratorOTHER
Advanced Medical Electronics
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Facilitators to Successful Implementation3 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 Implementation3 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

MeasureTime frameDescription
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.3 weeks\[Questionnaires\] Assessment of users' perceived ease of use and usefulness of using the technology. There are two sub-scales, with 6 questions each: 1. Perceived Usefulness, Min score = 1 (extremely unlikely), max score = 7 (extremely likely) 2. Perceived Ease of Use: Min score = 1 (extremely unlikely), max score = 7 (extremely likely) We also calculated an overall score which consists of all 12 questions: 3. Overall: Min score = 1 (extremely unlikely), max score = 7 (extremely likely)
Technology Acceptance and Adoption3 weeks\[Interview\] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology. A content analysis of the qualitative data was conducted. This identified themes, such as music or trivia. We report the frequency of each theme mentioned during the interview.
Robotic Social Attributes Scale (RoSAS): Family & Staff3 weeks\[Questionnaire\] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort. An 18-item scale (1-7) with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort. There are three sub-scales, with 6 questions each: 1. Warmth: Min score = 1 (not at all), max score = 7 (very much so) 2. Competency: Min score = 1 (not at all), max score = 7 (very much so) 3. Discomfort: Min score = 1 (not at all), max score = 7 (very much so)
Robotic Social Attributes Scale (RoSAS): Residents3 weeks\[Questionnaire\] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort. An 18-item scale (1-3) with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort. Residents completed a simpler version of the RoSAS. There are three sub-scales, with 6 questions each: 1. Warmth: Min score = 1 (Yes), max score = 3 (No) 2. Competency: Min score = 1 (Yes), max score = 3 (No) 3. Discomfort: Min score = 1 (Yes), max score = 3 (No)
Robot Social Attributes3 weeks\[Interview\] Social Assistive Robot social attributes are identified (e.g., friendliness, competency, etc). A content analysis of the qualitative data was conducted. This identified themes, such as appearance or understanding. We report the frequency of each theme mentioned during the interview.
Usability and Usefulness3 weeks\[Interview\] Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of interview. A content analysis of the qualitative data was conducted. We report the frequency of the theme 'useful' and 'helpful' being mentioned during the interview.
Conversation Quality3 weeks\[Interview\] User perceptions on the usefulness and ease of use in conversing with the technology. A content analysis of the qualitative data was conducted. We report the frequency of the themes related to conversation quality mentioned during the interview, for example "understand" or "voice".
Value Proposition/Economic Impact3 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. A content analysis of the qualitative data was conducted. We report the frequency of the use cases mentioned during the interview, for example "music" or "trivia" as high-value propositions.
Requirements3 weeks\[Interview + Observations\] Identified requirements for design, training, and communication as derived from analysis of interview, observations. A content analysis of the qualitative data was conducted. We report the number of requirements mentioned \& identified during the interview and observation, for example, enhancing audio features or updating the robot remotely.
Affect3 weeks\[Interview\] Feelings of enjoyment, satisfaction, when using the technology. A content analysis of the qualitative data was conducted. We report the frequency of themes mentioned during the interview, for example "fun" or "engage".
Guilt Scale3 weeks\[Questionnaire\] Guilt Scale. A 3 question, 4-point scale (0 = not at all; 3 = almost unbearable), with a higher score indicating higher guilt for a composite score range of 0 to 9. Only completed by one participant group: Family members

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnne Adams, PhD

SimpleC, LLC

PRINCIPAL_INVESTIGATORJenay Beer, PhD

jenay.beer@uga.edu

Participant flow

Pre-assignment details

Participants who consented but did not meet the inclusion criteria were administratively withdrawn.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
9 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
Age, Continuous63 years
STANDARD_DEVIATION 18
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Guilt2.29 units on a scale
STANDARD_DEVIATION 1.11
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
4 Participants
Region of Enrollment
United States
7 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 70 / 8
other
Total, other adverse events
1 / 80 / 70 / 8
serious
Total, serious adverse events
0 / 80 / 70 / 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026