- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05599503
SimpleC Wellness Platform With Social Robot Interaction (Long-term)
Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Are existing and new residents engaged and satisfied with the Technology Intervention Program?
- What are the benefits (health, behavioral, economic, and social) of the virtual agent and physical robot?
- Which users will adopt the SAR system?
- What are facilitators and barriers to SAR system adoption?
- Does Technology Acceptance Theory explain adoption over time?
- Do changing needs affect changing technology attitude?
- 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.
- Participants in both conditions will have access to personal media, reminders, televisit, messaging, news, and wellness programs in their own room via the Companion.
- 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.
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne Adams, PhD
- Phone Number: 770.290.0035
- Email: aadams@simplec.com
Study Contact Backup
- Name: Jenay M Beer, PhD
- Phone Number: 404.308.4523
- Email: jenay.beer@uga.edu
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- University of Georgia
-
Atlanta, Georgia, United States, 30060
- SimpleC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Resident Inclusion Criteria:
- Aged 50+ years
- Any gender
- Fluent in English
- New or current user of SimpleC
- At risk for MCI; MCI; moderate / cognitive impairment (MMSE score of 13 or higher)
Family Member Inclusion Criteria:
- Aged 18+ years
- Any gender
- Fluent in English
- Family or friend of resident
- New or current user of SimpleC
- No diagnosis of dementia or related disorder
Staff Inclusion Criteria:
- Aged 18+ years
- Any gender
- Fluent in English
- Works for the Senior Housing Community
- New or current user of SimpleC
Resident Exclusion Criteria:
- Comorbidities or psychiatric history that would preclude study participation
- Expecting to move during the study (i.e., move out of facility)
- Both legally deaf and blind
- Not able to press tablet buttons
- Not able to verbally answer questionnaires
- Pregnant
Family Caregiver Exclusion Criteria:
- Comorbidities or psychiatric history that would preclude study participation
- Expecting to move during the study (i.e., move out of facility)
- Both legally deaf and blind
- Not able to press tablet buttons
- Pregnant
Staff Exclusion Criteria:
- Expecting to move during the study (i.e., move out of facility)
- Both legally deaf and blind
- Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SimpleC Wellness Platform with Social Robot Interaction
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).
|
Traditional SimpleC Wellness
Robot interventions
|
Active Comparator: SimpleC Wellness Platform
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.
|
Traditional SimpleC Wellness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Midpoint (3 months), Final (6 months)
|
[Questionnaire] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort
|
Midpoint (3 months), Final (6 months)
|
Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.
Time Frame: Baseline, Midpoint (3 months), Final (6 months)
|
[Questionnaire] Family caregiver feelings of guilt.
|
Baseline, Midpoint (3 months), Final (6 months)
|
Change in Perceived Stress Scale. A 5-point scale with higher scores indicating higher stress.
Time Frame: Baseline, Midpoint (3 months), Final (6 months)
|
[Questionnaire] Family caregiver experience of stress in the past 4 months.
Modification: Answer as it relates to caregiving.
|
Baseline, Midpoint (3 months), Final (6 months)
|
Change in Technology Acceptance and Experience Questionnaire. A scale with high scores indicating higher acceptance.
Time Frame: Midpoint (3 months), Final (6 months)
|
[Questionnaire] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.
|
Midpoint (3 months), Final (6 months)
|
Change in Quality of Life. A 13-item survey with high scores indicating higher quality of life.
Time Frame: Baseline, Midpoint (3 months), Final (6 months)
|
[Questionnaire] Assessment of different aspects of quality of life, including physical health, energy, family, money.
|
Baseline, Midpoint (3 months), Final (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technology acceptance and adoption Interview.
Time Frame: Midpoint (3 months)
|
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
|
Midpoint (3 months)
|
Technology acceptance and adoption Interview.
Time Frame: Final (6 months)
|
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
|
Final (6 months)
|
Usability and usefulness
Time Frame: 6 months
|
Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]
|
6 months
|
Conversation quality
Time Frame: 6 months
|
[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.
|
6 months
|
Value proposition/Economic Impact
Time Frame: 6 months
|
[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.
|
6 months
|
Requirements
Time Frame: 6 months
|
Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]
|
6 months
|
Affect
Time Frame: 6 months
|
[Interview] Feelings of enjoyment, satisfaction, when using the technology
|
6 months
|
Participation Pattern
Time Frame: 6 months
|
How often system is used, buttons clicked, voice activation [usage data, interview, observations]
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Adams, PhD, SimpleC, LLC
- Principal Investigator: Jenay M Beer, PhD, University of Georgia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7645D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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