SimpleC Wellness Platform With Social Robot Interaction

March 4, 2026 updated by: SimpleC, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Athens, Georgia, United States, 30602
        • University of Georgia
      • Atlanta, Georgia, United States, 30060
        • SimpleC, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SimpleC Wellness Platform with Social Robot Interaction
Three participant groups: Residents, family members, and staff
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 weeks
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.
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
Time Frame: 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)
3 weeks
Technology Acceptance and Adoption
Time Frame: 3 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.
3 weeks
Robotic Social Attributes Scale (RoSAS): Family & Staff
Time Frame: 3 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)
3 weeks
Robotic Social Attributes Scale (RoSAS): Residents
Time Frame: 3 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)
3 weeks
Robot Social Attributes
Time Frame: 3 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.
3 weeks
Usability and Usefulness
Time Frame: 3 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.
3 weeks
Conversation Quality
Time Frame: 3 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".
3 weeks
Value Proposition/Economic Impact
Time Frame: 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. 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.
3 weeks
Requirements
Time Frame: 3 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.
3 weeks
Affect
Time Frame: 3 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".
3 weeks
Guilt Scale
Time Frame: 3 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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SimpleC, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Georgia
Advanced Medical Electronics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Adams, PhD, SimpleC, LLC
  • Principal Investigator: Jenay Beer, PhD, jenay.beer@uga.edu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7645C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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