An interventional study of SimpleC Wellness Platform with Social Robot Interaction in Engagement, Patient, Mood and Quality of Life, sponsored by SimpleC, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by SimpleC, LLC · Not applicable, Interventional, and Other
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.
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:
What are the desired parameters that the SAR system should have?
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.
127 studies on the registry are indexed under Patient Participation; 64 are open to participants now.
This study's enrollment of 26 is below the median of 138 across 105 interventional studies indexed under Patient Participation.
Browse Patient Participation studies →SimpleC, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 3 weeks
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: 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)
Time frame: 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.
Time frame: 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: 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)
Time frame: 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: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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
Time frame: 3 weeks
| Milestone | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Started | 11 | 7 | 8 |
| Completed | 8 | 7 | 6 |
| Not completed | 3 | 0 | 2 |
\[Interview\] 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.
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Useful, helpful, benefit, innovative | 33 | 30 | 24 |
| Engage, interact, fun, enjoy, entertain | 27 | 30 | 35 |
| Tech experience (positive) | 3 | 3 | 1 |
\[Interview\] 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.
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Hard to use, difficult, not useful, dislike | 3 | 1 | 0 |
| Training | 0 | 3 | 5 |
| Tech experience (negative) | 5 | 0 | 1 |
\[Questionnaires\] 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)
| units on a scale | Family Members | Staff |
|---|---|---|
| SAR Overall | 5.83 ± .08 | 5.82 ± .42 |
| SARv Overall | 6.14 ± .25 | 5.75 ± .68 |
| SAR Perceived Usefulness | 5.22 ± .10 | 5.71 ± .81 |
| SARv Perceived Usefulness | 5.67 ± .17 | 5.50 ± 1.17 |
| SAR Perceived Ease of use | 6.44 ± .19 | 5.93 ± .30 |
| SARv Perceived Ease of use | 6.61 ± .42 | 6.00 ± .33 |
\[Interview\] 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.
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Music | 16 | 19 | 5 |
| Video | 0 | 3 | 0 |
| Pictures, photos, image | 5 | 9 | 4 |
| Trivia | 18 | 6 | 6 |
| Reminder | 14 | 17 | 13 |
\[Questionnaire\] 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)
| score on a scale | Family Members | Staff |
|---|---|---|
| SAR Warmth | 4.89 ± 0.38 | 4.25 ± 1.24 |
| SARv Warmth | 4.83 ± 0.58 | 3.92 ± 1.77 |
| SAR Competence | 5.28 ± .10 | 5.79 ± 0.21 |
| SARv Competence | 5.28 ± 0.59 | 6.25 ± 0.35 |
| SAR Discomfort | 1.67 ± 0.44 | 1.33 ± .47 |
| SARv Discomfort | 1.67 ± 0.17 | 1.17 ± .24 |
\[Questionnaire\] 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)
| score on a scale | Residents |
|---|---|
| SAR Warmth | 2.00 ± .72 |
| SARv Warmth | 2.33 ± .82 |
| SAR Competence | 2.53 ± .45 |
| SARv Competence | 2.83 ± 1.00 |
| SAR Discomfort | 1.11 ± .14 |
| SARv Discomfort | 1.08 ± .42 |
\[Interview\] 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.
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Appearance, look, face | 7 | 2 | 2 |
| Understand, understood, voice | 9 | 1 | 1 |
\[Interview\] 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.
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Usability and Usefulness | 33 | 30 | 24 |
\[Interview\] 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".
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Conversation Quality | 9 | 1 | 1 |
\[Interview\] 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.
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Music | 16 | 19 | 5 |
| Trivia | 18 | 6 | 6 |
| Reminders | 14 | 17 | 13 |
\[Interview + Observations\] 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.
| Number of requirements identified | All Participants |
|---|---|
| Requirements | 11 |
\[Interview\] 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".
| Total number of mentions | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Affect | 27 | 30 | 35 |
\[Questionnaire\] 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
| units on a scale | Family Caregivers |
|---|---|
| Guilt Scale | 1.57 ± .98 |
Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Residents | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Family Caregivers | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Staff | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Event | Residents | Family Caregivers | Staff |
|---|---|---|---|
| Mild Adverse EventSocial circumstances | 1/8 | 0/7 | 0/8 |
Baseline analysis includes data from 3 participants groups: (1) Residents (n=8), (2) Family members (n=7), and (3) Staff members (n=8). Data from 3 participants (Residents (n=3) were excluded from Baseline because participants were administrative withdrawn after providing consent but before Baseline was completed. This explains the discrepancy between total number of Residents in the Overall Study (N=11) vs. total number of residents at Baseline (N=8).
| Age, Categorical(Participants) | Residents | Family Caregivers | Staff | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 7 | 7 | 14 |
| >=65 years | 8 | 0 | 1 | 9 |
| Age, Continuous(years) | Residents | Family Caregivers | Staff | Total |
|---|---|---|---|---|
| Mean | 83 ± 10 | 57 ± 6 | 49 ± 14 | 63 ± 18 |
| Sex: Female, Male(Participants) | Residents | Family Caregivers | Staff | Total |
|---|---|---|---|---|
| Female | 6 | 2 | 6 | 14 |
| Male | 2 | 5 | 2 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Residents | Family Caregivers | Staff | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 8 | 7 | 6 | 21 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Residents | Family Caregivers | Staff | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 4 | 10 |
| White | 4 | 4 | 2 | 10 |
| More than one race | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Residents | Family Caregivers | Staff | Total |
|---|---|---|---|---|
| United States | 8 | 7 | 8 | 23 |
| Guilt(units on a scale) | Residents | Family Caregivers | Staff | Total |
|---|---|---|---|---|
| Mean | — | 2.29 ± 1.11 | — | 2.29 ± 1.11 |
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