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| Name | Class |
|---|---|
| University of Georgia | OTHER |
| Advanced Medical Electronics | OTHER |
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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:
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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SimpleC Wellness Platform with Social Robot Interaction | Experimental | Three participant groups: Residents, family members, and staff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SimpleC Wellness Platform with Social Robot Interaction | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Adams, PhD | SimpleC, LLC | Principal Investigator |
| Jenay Beer, PhD | jenay.beer@uga.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States | ||
| SimpleC, LLC |
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Participants who consented but did not meet the inclusion criteria were administratively withdrawn.
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| ID | Title | Description |
|---|---|---|
| FG000 | Residents | Residents in Assisted Living |
| FG001 | Family Caregivers | Family Caregivers of Residents in Assisted Living |
| FG002 | Staff | Staff Caregivers in Assisted Living |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Residents | Residents in Assisted Living |
| BG001 | Family Caregivers | Family Caregivers of Residents in Assisted Living |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks | Total number of mentions | Total number of mentions |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Residents | Residents in Assisted Living | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Adverse Event | Social circumstances | Systematic Assessment | Emotional distress in response to questions about contentment, loneliness, and life. |
We experienced SARS-COV-2 related restrictions in availability, flexibility, and access to community, staff, and residents.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Adams | SimpleC LLC | 770.290.0031 | aadams@simplec.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2022 | Aug 7, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2022 | Jan 21, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| 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. | 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:
| 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:
| 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. | 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. | 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". | 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. | 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. | 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". | 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 | 3 weeks |
| Atlanta |
| Georgia |
| 30060 |
| United States |
| BG002 | Staff | Staff Caregivers in Assisted Living |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Guilt | 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. | The Guilt survey was only administered to family caregivers (n=7). | Mean | Standard Deviation | units on a scale |
|
| OG002 | Staff | Staff Caregivers in Assisted Living |
|
|
| Primary | 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. | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks | Total number of mentions | Total number of mentions |
|
|
|
| Secondary | 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:
| Not all Staff members experienced SARv and completed the Questionnaire for SARv. The measure was not administered to Residents. | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
|
|
| Secondary | 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. | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks | Total number of mentions | Total number of mentions |
|
|
|
| Secondary | 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:
| Not all staff members saw the virtual robot (SARv). | Posted | Mean | Standard Deviation | score on a scale | 3 weeks |
|
|
|
| Secondary | 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:
| Not all residents saw the virtual robot (SARv). | Posted | Mean | Standard Deviation | score on a scale | 3 weeks |
|
|
|
| Secondary | 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. | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks | Total number of mentions | Total number of mentions |
|
|
|
| Secondary | 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. | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks |
|
|
|
| Secondary | 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". | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks |
|
|
|
| Secondary | 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. | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks | Total number of mentions | Total number of mentions |
|
|
|
| Secondary | 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. | Qualitative, thematic analysis of various data sources, including observations of participant interactions across arms. Therefore separating by arm is not viable, and the list of design requirements represents all participants. | Posted | Number | Number of requirements identified | 3 weeks |
|
|
|
| Secondary | 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". | Qualitative, thematic analysis | Posted | Number | Total number of mentions | 3 weeks |
|
|
|
| Secondary | 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 | The Guilt scale was only administered to family caregivers (n=7) | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
|
|
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Family Caregivers | Family Caregivers of Residents in Assisted Living | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Staff | Staff Caregivers in Assisted Living | 0 | 8 | 0 | 8 | 0 | 8 |
|
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| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Tech experience (negative) |
|
| SARv Overall |
|
|
| SAR Perceived Usefulness |
|
|
| SARv Perceived Usefulness |
|
|
| SAR Perceived Ease of use |
|
|
| SARv Perceived Ease of use |
|
|
| Title | Measurements |
|---|---|
|
| Pictures, photos, image |
|
| Trivia |
|
| Reminder |
|
| SARv Warmth |
|
|
| SAR Competence |
|
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| SARv Competence |
|
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| SAR Discomfort |
|
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| SARv Discomfort |
|
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| SAR Competence |
|
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| SARv Competence |
|
|
| SAR Discomfort |
|
|
| SARv Discomfort |
|
|
|
| Title | Measurements |
|---|---|
|
| Reminders |
|