Trial Outcomes & Findings for SimpleC Wellness Platform With Social Robot Interaction (NCT NCT05296239)
NCT ID: NCT05296239
Last Updated: 2026-03-05
Results Overview
\[Interview\] 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.
COMPLETED
NA
26 participants
3 weeks
2026-03-05
Participant Flow
Participants who consented but did not meet the inclusion criteria were administratively withdrawn.
Participant milestones
| Measure |
Residents
Residents in Assisted Living
|
Family Caregivers
Family Caregivers of Residents in Assisted Living
|
Staff
Staff Caregivers in Assisted Living
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Guilt survey was only administered to family caregivers (n=7).
Baseline characteristics by cohort
| Measure |
Residents
n=8 Participants
Residents in Assisted Living
|
Family Caregivers
n=7 Participants
Family Caregivers of Residents in Assisted Living
|
Staff
n=8 Participants
Staff Caregivers in Assisted Living
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=8 Participants
|
14 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=23 Participants
|
|
Age, Continuous
|
83 years
STANDARD_DEVIATION 10 • n=8 Participants
|
57 years
STANDARD_DEVIATION 6 • n=7 Participants
|
49 years
STANDARD_DEVIATION 14 • n=8 Participants
|
63 years
STANDARD_DEVIATION 18 • n=23 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
14 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=8 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
21 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
10 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
7 participants
n=7 Participants
|
8 participants
n=8 Participants
|
23 participants
n=23 Participants
|
|
Guilt
|
—
|
2.29 units on a scale
STANDARD_DEVIATION 1.11 • n=7 Participants • The Guilt survey was only administered to family caregivers (n=7).
|
—
|
2.29 units on a scale
STANDARD_DEVIATION 1.11 • n=7 Participants • The Guilt survey was only administered to family caregivers (n=7).
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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.
Outcome measures
| Measure |
Family Caregivers
n=63 Total number of mentions
Family Caregivers of Residents in Assisted Living
|
Staff
n=60 Total number of mentions
Staff Caregivers in Assisted Living
|
Residents
n=63 Total number of mentions
Residents in Assisted Living
|
|---|---|---|---|
|
Facilitators to Successful Implementation
Useful, helpful, benefit, innovative
|
30 Total number of mentions
|
24 Total number of mentions
|
33 Total number of mentions
|
|
Facilitators to Successful Implementation
Engage, interact, fun, enjoy, entertain
|
30 Total number of mentions
|
35 Total number of mentions
|
27 Total number of mentions
|
|
Facilitators to Successful Implementation
Tech experience (positive)
|
3 Total number of mentions
|
1 Total number of mentions
|
3 Total number of mentions
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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.
Outcome measures
| Measure |
Family Caregivers
n=4 Total number of mentions
Family Caregivers of Residents in Assisted Living
|
Staff
n=6 Total number of mentions
Staff Caregivers in Assisted Living
|
Residents
n=8 Total number of mentions
Residents in Assisted Living
|
|---|---|---|---|
|
Barriers to Successful Implementation
Hard to use, difficult, not useful, dislike
|
1 Total number of mentions
|
0 Total number of mentions
|
3 Total number of mentions
|
|
Barriers to Successful Implementation
Training
|
3 Total number of mentions
|
5 Total number of mentions
|
0 Total number of mentions
|
|
Barriers to Successful Implementation
Tech experience (negative)
|
0 Total number of mentions
|
1 Total number of mentions
|
5 Total number of mentions
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Not all Staff members experienced SARv and completed the Questionnaire for SARv. The measure was not administered to Residents.
\[Questionnaires\] 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)
Outcome measures
| Measure |
Family Caregivers
n=5 Participants
Family Caregivers of Residents in Assisted Living
|
Staff
Staff Caregivers in Assisted Living
|
Residents
n=3 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
SARv Overall
|
5.75 units on a scale
Standard Deviation .68
|
—
|
6.14 units on a scale
Standard Deviation .25
|
|
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
SAR Perceived Usefulness
|
5.71 units on a scale
Standard Deviation .81
|
—
|
5.22 units on a scale
Standard Deviation .10
|
|
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
SAR Perceived Ease of use
|
5.93 units on a scale
Standard Deviation .30
|
—
|
6.44 units on a scale
Standard Deviation .19
|
|
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
SARv Perceived Ease of use
|
6.00 units on a scale
Standard Deviation .33
|
—
|
6.61 units on a scale
Standard Deviation .42
|
|
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
SAR Overall
|
5.82 units on a scale
Standard Deviation .42
|
—
|
5.83 units on a scale
Standard Deviation .08
|
|
Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.
SARv Perceived Usefulness
|
5.50 units on a scale
Standard Deviation 1.17
|
—
|
5.67 units on a scale
Standard Deviation .17
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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.
Outcome measures
| Measure |
Family Caregivers
n=54 Total number of mentions
Family Caregivers of Residents in Assisted Living
|
Staff
n=28 Total number of mentions
Staff Caregivers in Assisted Living
|
Residents
n=53 Total number of mentions
Residents in Assisted Living
|
|---|---|---|---|
|
Technology Acceptance and Adoption
Music
|
19 Total number of mentions
|
5 Total number of mentions
|
16 Total number of mentions
|
|
Technology Acceptance and Adoption
Video
|
3 Total number of mentions
|
0 Total number of mentions
|
0 Total number of mentions
|
|
Technology Acceptance and Adoption
Pictures, photos, image
|
9 Total number of mentions
|
4 Total number of mentions
|
5 Total number of mentions
|
|
Technology Acceptance and Adoption
Trivia
|
6 Total number of mentions
|
6 Total number of mentions
|
18 Total number of mentions
|
|
Technology Acceptance and Adoption
Reminder
|
17 Total number of mentions
|
13 Total number of mentions
|
14 Total number of mentions
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Not all staff members saw the virtual robot (SARv).
\[Questionnaire\] 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)
Outcome measures
| Measure |
Family Caregivers
n=4 Participants
Family Caregivers of Residents in Assisted Living
|
Staff
Staff Caregivers in Assisted Living
|
Residents
n=3 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Robotic Social Attributes Scale (RoSAS): Family & Staff
SAR Warmth
|
4.25 score on a scale
Standard Deviation 1.24
|
—
|
4.89 score on a scale
Standard Deviation 0.38
|
|
Robotic Social Attributes Scale (RoSAS): Family & Staff
SARv Warmth
|
3.92 score on a scale
Standard Deviation 1.77
|
—
|
4.83 score on a scale
Standard Deviation 0.58
|
|
Robotic Social Attributes Scale (RoSAS): Family & Staff
SAR Competence
|
5.79 score on a scale
Standard Deviation 0.21
|
—
|
5.28 score on a scale
Standard Deviation .10
|
|
Robotic Social Attributes Scale (RoSAS): Family & Staff
SARv Competence
|
6.25 score on a scale
Standard Deviation 0.35
|
—
|
5.28 score on a scale
Standard Deviation 0.59
|
|
Robotic Social Attributes Scale (RoSAS): Family & Staff
SAR Discomfort
|
1.33 score on a scale
Standard Deviation .47
|
—
|
1.67 score on a scale
Standard Deviation 0.44
|
|
Robotic Social Attributes Scale (RoSAS): Family & Staff
SARv Discomfort
|
1.17 score on a scale
Standard Deviation .24
|
—
|
1.67 score on a scale
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Not all residents saw the virtual robot (SARv).
\[Questionnaire\] 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)
Outcome measures
| Measure |
Family Caregivers
Family Caregivers of Residents in Assisted Living
|
Staff
Staff Caregivers in Assisted Living
|
Residents
n=6 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Robotic Social Attributes Scale (RoSAS): Residents
SAR Warmth
|
—
|
—
|
2.00 score on a scale
Standard Deviation .72
|
|
Robotic Social Attributes Scale (RoSAS): Residents
SARv Warmth
|
—
|
—
|
2.33 score on a scale
Standard Deviation .82
|
|
Robotic Social Attributes Scale (RoSAS): Residents
SAR Competence
|
—
|
—
|
2.53 score on a scale
Standard Deviation .45
|
|
Robotic Social Attributes Scale (RoSAS): Residents
SARv Competence
|
—
|
—
|
2.83 score on a scale
Standard Deviation 1.00
|
|
Robotic Social Attributes Scale (RoSAS): Residents
SAR Discomfort
|
—
|
—
|
1.11 score on a scale
Standard Deviation .14
|
|
Robotic Social Attributes Scale (RoSAS): Residents
SARv Discomfort
|
—
|
—
|
1.08 score on a scale
Standard Deviation .42
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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.
Outcome measures
| Measure |
Family Caregivers
n=3 Total number of mentions
Family Caregivers of Residents in Assisted Living
|
Staff
n=3 Total number of mentions
Staff Caregivers in Assisted Living
|
Residents
n=16 Total number of mentions
Residents in Assisted Living
|
|---|---|---|---|
|
Robot Social Attributes
Understand, understood, voice
|
1 Total number of mentions
|
1 Total number of mentions
|
9 Total number of mentions
|
|
Robot Social Attributes
Appearance, look, face
|
2 Total number of mentions
|
2 Total number of mentions
|
7 Total number of mentions
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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.
Outcome measures
| Measure |
Family Caregivers
n=7 Participants
Family Caregivers of Residents in Assisted Living
|
Staff
n=5 Participants
Staff Caregivers in Assisted Living
|
Residents
n=7 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Usability and Usefulness
|
30 Total number of mentions
|
24 Total number of mentions
|
33 Total number of mentions
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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".
Outcome measures
| Measure |
Family Caregivers
n=7 Participants
Family Caregivers of Residents in Assisted Living
|
Staff
n=5 Participants
Staff Caregivers in Assisted Living
|
Residents
n=7 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Conversation Quality
|
1 Total number of mentions
|
1 Total number of mentions
|
9 Total number of mentions
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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.
Outcome measures
| Measure |
Family Caregivers
n=42 Total number of mentions
Family Caregivers of Residents in Assisted Living
|
Staff
n=24 Total number of mentions
Staff Caregivers in Assisted Living
|
Residents
n=48 Total number of mentions
Residents in Assisted Living
|
|---|---|---|---|
|
Value Proposition/Economic Impact
Music
|
19 Total number of mentions
|
5 Total number of mentions
|
16 Total number of mentions
|
|
Value Proposition/Economic Impact
Trivia
|
6 Total number of mentions
|
6 Total number of mentions
|
18 Total number of mentions
|
|
Value Proposition/Economic Impact
Reminders
|
17 Total number of mentions
|
13 Total number of mentions
|
14 Total number of mentions
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: 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.
\[Interview + Observations\] 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.
Outcome measures
| Measure |
Family Caregivers
Family Caregivers of Residents in Assisted Living
|
Staff
Staff Caregivers in Assisted Living
|
Residents
n=19 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Requirements
|
—
|
—
|
11 Number of requirements identified
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Qualitative, thematic analysis
\[Interview\] 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".
Outcome measures
| Measure |
Family Caregivers
n=7 Participants
Family Caregivers of Residents in Assisted Living
|
Staff
n=5 Participants
Staff Caregivers in Assisted Living
|
Residents
n=7 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Affect
|
30 Total number of mentions
|
35 Total number of mentions
|
27 Total number of mentions
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: The Guilt scale was only administered to family caregivers (n=7)
\[Questionnaire\] 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
Outcome measures
| Measure |
Family Caregivers
Family Caregivers of Residents in Assisted Living
|
Staff
Staff Caregivers in Assisted Living
|
Residents
n=7 Participants
Residents in Assisted Living
|
|---|---|---|---|
|
Guilt Scale
|
—
|
—
|
1.57 units on a scale
Standard Deviation .98
|
Adverse Events
Residents
Family Caregivers
Staff
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Residents
n=8 participants at risk
Residents in Assisted Living
|
Family Caregivers
n=7 participants at risk
Family Caregivers of Residents in Assisted Living
|
Staff
n=8 participants at risk
Staff Caregivers in Assisted Living
|
|---|---|---|---|
|
Social circumstances
Mild Adverse Event
|
12.5%
1/8 • Number of events 1 • 3 weeks
|
0.00%
0/7 • 3 weeks
|
0.00%
0/8 • 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place