Engagement, PatientNCT05296239
SimpleC Wellness Platform With Social Robot Interaction
A study testing SimpleC Wellness Platform with Social Robot Interaction in people with Engagement, Patient and Mood, run by SimpleC, LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Engagement, Patient, Mood, Quality of Life
- What is being tested?
- SimpleC Wellness Platform with Social Robot Interaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Feb 2022to 7 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Family member: no diagnosis of dementia or related disorder
- Staff: 18 years and older
- Staff: works for the Senior Housing Community
Who cannot join
- All: pregnant
- Resident: Expecting to move during the study
- Resident: Both legally deaf and blind
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Georgia
Athens, Georgia, 30602
SimpleC, LLC
Atlanta, Georgia, 30060
About this study
Official title: 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.
Read the 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.
- Conditions
- Engagement, Patient, Mood, Quality of Life, Aging, Mild Cognitive Impairment, Cognitive Impairment
- Being tested
- SimpleC Wellness Platform with Social Robot Interaction
- Keywords
- At risk, Diagnosis
- Medical subject headings
- Patient Participation, Cognitive Dysfunction, Dementia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimpleC Wellness Platform with Social Robot InteractionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SimpleC Wellness Platform with Social Robot Interaction | Experimental | Three participant groups: Residents, family members, and staff Receives: Other: SimpleC Wellness Platform with Social Robot Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facilitators to Successful Implementation
[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.
Measured: 3 weeks
Barriers to Successful Implementation
[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.
Measured: 3 weeks
Secondary outcomes (11)
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
[Questionnaires] Assessment of users' perceived ease of use and usefulness of using the technology.
There are two sub-scales, with 6 questions each:
- Perceived Usefulness, Min score = 1 (extremely unlikely), max score = 7 (extremely likely)
- 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:
- Overall: Min score = 1 (extremely unlikely), max score = 7 (extremely likely)
Measured: 3 weeks
Technology Acceptance and Adoption
[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.
Measured: 3 weeks
Robotic Social Attributes Scale (RoSAS): Family & Staff
[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:
- Warmth: Min score = 1 (not at all), max score = 7 (very much so)
- Competency: Min score = 1 (not at all), max score = 7 (very much so)
- Discomfort: Min score = 1 (not at all), max score = 7 (very much so)
Measured: 3 weeks
Robotic Social Attributes Scale (RoSAS): Residents
[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:
- Warmth: Min score = 1 (Yes), max score = 3 (No)
- Competency: Min score = 1 (Yes), max score = 3 (No)
- Discomfort: Min score = 1 (Yes), max score = 3 (No)
Measured: 3 weeks
Robot Social Attributes
[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.
Measured: 3 weeks
Usability and Usefulness
[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.
Measured: 3 weeks
Conversation Quality
[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".
Measured: 3 weeks
Value Proposition/Economic Impact
[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.
Measured: 3 weeks
Requirements
[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.
Measured: 3 weeks
Affect
[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".
Measured: 3 weeks
Guilt Scale
[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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start3 Feb 2022
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Engagement, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- SimpleC, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Georgia, Advanced Medical Electronics
- Responsible party
- Sponsor
- Investigators
- Anne Adams, PhD, Principal investigator, SimpleC, LLCJenay Beer, PhD, Principal investigator, jenay.beer@uga.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296239
- Sponsor's protocol ID
- 7645C
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2022
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
- ClinicalTrials.gov ID
- NCT05296239
- Acronym / sponsor ID
- 7645C
- Conditions
- Engagement, Patient, Mood, Quality of Life, Aging, Mild Cognitive Impairment, Cognitive Impairment
- Keywords
- At risk, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- SimpleC, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Georgia, Advanced Medical Electronics
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Posted 5 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SimpleC Wellness Platform with Social Robot Interaction | Experimental | Other: SimpleC Wellness Platform with Social Robot InteractionThree participant groups: Residents, family members, and staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- All: pregnant
- Resident: Expecting to move during the study
- Resident: Both legally deaf and blind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimpleC Wellness Platform with Social Robot InteractionOnce 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. | Other | SimpleC Wellness Platform with Social Robot Interaction |
Primary outcome
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.
11 secondary outcomes
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
Time frame: 3 weeks
Technology Acceptance and Adoption
Time frame: 3 weeks
Robotic Social Attributes Scale (RoSAS): Family & Staff
Time frame: 3 weeks
Robotic Social Attributes Scale (RoSAS): Residents
Time frame: 3 weeks
Robot Social Attributes
Time frame: 3 weeks
Usability and Usefulness
Time frame: 3 weeks
Conversation Quality
Time frame: 3 weeks
Value Proposition/Economic Impact
Time frame: 3 weeks
Requirements
Time frame: 3 weeks
Affect
Time frame: 3 weeks
Guilt Scale
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Engagement, Patient
Active, not recruiting
The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
Communication
Not yet recruiting
Increasing Breast and Colorectal Cancer Screening in the Community
Colorectal Neoplasms, Breast Neoplasms
Recruiting
Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates, Family HOPE Study
Hematopoietic and Lymphoid System Neoplasm, Hereditary Malignant Neoplasm
Not yet recruiting
A Study of Engagement in the "Résonance(s)" Musical and Experiential Immersion Program Among Patients With Mental Disorders - IRIS
Chronic Mental Disorders
Not yet recruiting
FIQS Dissemination and Implementation
Inpatient Experience Survey Administration, Inpatient Experience Survey Response
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Adams, PhD principal investigator
SimpleC, LLC
Jenay Beer, PhD principal investigator
jenay.beer@uga.edu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SimpleC Wellness Platform with Social Robot Interaction in people with Engagement, Patient and Mood, run by SimpleC, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facilitators to Successful Implementation (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.