An interventional study of Behavioral Interventions and Robot Interventions in Engagement, Patient, Quality of Life and Mood, sponsored by SimpleC, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by SimpleC, LLC · Not applicable, Interventional, and Supportive care
This 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 mixed-method study to assess the effectiveness of the SAR system. The study includes behavior/lifestyle intervention that are delivered via a robot and/or tablet. The study intervention is a Social Assistive Robot (SAR) System. The SAR system contains the SimpleC Platform, physical robot, virtual agent/robot.
The goal is to engage residents in a natural language conversation as psychosocial support (enhancing mood, mitigating the effects of loneliness, and enhancing social connection and communication) and provide value to the organization and its staff.
Research questions include:
Sample: 270 individuals will participate: 90 residents, 90 family, and 90 staff across different study locations. Enrollment will be stopped upon reaching saturation.
The goal is to offer SAR-facilitated group session at least once per week, for residents to attend at least one such session over the course of the study and two sessions/month.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 63 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →SimpleC, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Resident Inclusion Criteria:
Family Member Inclusion Criteria:
Staff Inclusion Criteria:
Resident Exclusion Criteria:
Family Caregiver Exclusion Criteria:
Staff Exclusion Criteria:
Participants in the Social Robot condition will have access to personal media, reminders, televisit, messaging, news, and wellness programs in their own room via the Companion. Participants will also will have access to social and health reminders as well as social and wellness programs facilitated by a virtual robot agent in their own room via the Companion, social and health reminders as well as social and wellness programs facilitated by a physical robot in the community area and a staff member (likely the activity director).
Behavioral: Behavioral Interventions · Behavioral: Robot Interventions
Participants in the SimpleC Wellness Platform condition will have access to personal media, reminders, televisit, messaging, news, and wellness programs in their own room via the Companion.
Behavioral: Behavioral Interventions
Traditional SimpleC Wellness
Robot interventions
Change in Robotic Social Attributes Scale (RoSAS). An 18-item scale with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort.
\[Questionnaire\] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort
Time frame: Midpoint (3 months), Final (6 months)
Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.
\[Questionnaire\] Family caregiver feelings of guilt.
Time frame: Baseline, Midpoint (3 months), Final (6 months)
Change in Perceived Stress Scale. A 5-point scale with higher scores indicating higher stress.
\[Questionnaire\] Family caregiver experience of stress in the past 4 months. Modification: Answer as it relates to caregiving.
Time frame: Baseline, Midpoint (3 months), Final (6 months)
Change in Technology Acceptance and Experience Questionnaire. A scale with high scores indicating higher acceptance.
\[Questionnaire\] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.
Time frame: Midpoint (3 months), Final (6 months)
Change in Quality of Life. A 13-item survey with high scores indicating higher quality of life.
\[Questionnaire\] Assessment of different aspects of quality of life, including physical health, energy, family, money.
Time frame: Baseline, Midpoint (3 months), Final (6 months)
Technology acceptance and adoption Interview.
\[Interview\] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Time frame: Midpoint (3 months)
Technology acceptance and adoption Interview.
\[Interview\] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Time frame: Final (6 months)
Usability and usefulness
Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: \[Interview, usage data\]
Time frame: 6 months
Conversation quality
\[Interview\] User perceptions on the usefulness and ease of use in conversing with the technology.
Time frame: 6 months
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.
Time frame: 6 months
Requirements
Identified requirements for design, training, and communication as derived from analysis of: \[Interview, observations\]
Time frame: 6 months
Affect
\[Interview\] Feelings of enjoyment, satisfaction, when using the technology
Time frame: 6 months
Participation Pattern
How often system is used, buttons clicked, voice activation \[usage data, interview, observations\]
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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