Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-01 @ 10:29 PM
Study NCT ID:
NCT05599503
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SimpleC Wellness Platform With Social Robot Interaction (Long-term)
Sponsor:
SimpleC, LLC
Organization:
Study Overview
Official Title:
Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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:
1. Are existing and new residents engaged and satisfied with the Technology Intervention Program?
2. What are the benefits (health, behavioral, economic, and social) of the virtual agent and physical robot?
3. Which users will adopt the SAR system?
4. What are facilitators and barriers to SAR system adoption?
5. Does Technology Acceptance Theory explain adoption over time?
6. Do changing needs affect changing technology attitude?
7. What are guidelines for implementation and design?
Sample: 270 individuals will participate: 90 residents, 90 family, and 90 staff across different study locations. Enrollment will be stopped upon reaching saturation.
1. Participants in both conditions will have access to personal media, reminders, televisit, messaging, news, and wellness programs in their own room via the Companion.
2. Participants in the SAR condition 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.
3. Participants in the SAR condition will also have access to 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).
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.
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:
1. Are existing and new residents engaged and satisfied with the Technology Intervention Program?
2. What are the benefits (health, behavioral, economic, and social) of the virtual agent and physical robot?
3. Which users will adopt the SAR system?
4. What are facilitators and barriers to SAR system adoption?
5. Does Technology Acceptance Theory explain adoption over time?
6. Do changing needs affect changing technology attitude?
7. What are guidelines for implementation and design?
Sample: 270 individuals will participate: 90 residents, 90 family, and 90 staff across different study locations. Enrollment will be stopped upon reaching saturation.
1. Participants in both conditions will have access to personal media, reminders, televisit, messaging, news, and wellness programs in their own room via the Companion.
2. Participants in the SAR condition 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.
3. Participants in the SAR condition will also have access to 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).
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: