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SimpleC Wellness Platform With Social Robot Interaction (Long-term)

Primary Purpose

Engagement, Patient, Quality of Life, Mood

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Interventions
Robot Interventions
Sponsored by
SimpleC, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Engagement, Patient focused on measuring At risk, diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of GeorgiaRecruiting
  • SimpleCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SimpleC Wellness Platform with Social Robot Interaction

SimpleC Wellness Platform

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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
Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.
[Questionnaire] Family caregiver feelings of guilt.
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.
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.
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.

Secondary Outcome Measures

Technology acceptance and adoption Interview.
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Technology acceptance and adoption Interview.
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Usability and usefulness
Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]
Conversation quality
[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.
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.
Requirements
Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]
Affect
[Interview] Feelings of enjoyment, satisfaction, when using the technology
Participation Pattern
How often system is used, buttons clicked, voice activation [usage data, interview, observations]

Full Information

First Posted
August 30, 2022
Last Updated
September 28, 2023
Sponsor
SimpleC, LLC
Collaborators
University of Georgia, Advanced Medical Electronics
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1. Study Identification

Unique Protocol Identification Number
NCT05599503
Brief Title
SimpleC Wellness Platform With Social Robot Interaction (Long-term)
Official Title
Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SimpleC, LLC
Collaborators
University of Georgia, Advanced Medical Electronics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Engagement, Patient, Quality of Life, Mood, Aging Well, Cognitive Change, Mild Cognitive Impairment, Cognitive Impairment, Dementia
Keywords
At risk, diagnosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SimpleC Wellness Platform with Social Robot Interaction
Arm Type
Experimental
Arm Description
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).
Arm Title
SimpleC Wellness Platform
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Interventions
Intervention Description
Traditional SimpleC Wellness
Intervention Type
Behavioral
Intervention Name(s)
Robot Interventions
Intervention Description
Robot interventions
Primary Outcome Measure Information:
Title
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.
Description
[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)
Title
Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.
Description
[Questionnaire] Family caregiver feelings of guilt.
Time Frame
Baseline, Midpoint (3 months), Final (6 months)
Title
Change in Perceived Stress Scale. A 5-point scale with higher scores indicating higher stress.
Description
[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)
Title
Change in Technology Acceptance and Experience Questionnaire. A scale with high scores indicating higher acceptance.
Description
[Questionnaire] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.
Time Frame
Midpoint (3 months), Final (6 months)
Title
Change in Quality of Life. A 13-item survey with high scores indicating higher quality of life.
Description
[Questionnaire] Assessment of different aspects of quality of life, including physical health, energy, family, money.
Time Frame
Baseline, Midpoint (3 months), Final (6 months)
Secondary Outcome Measure Information:
Title
Technology acceptance and adoption Interview.
Description
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Time Frame
Midpoint (3 months)
Title
Technology acceptance and adoption Interview.
Description
[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Time Frame
Final (6 months)
Title
Usability and usefulness
Description
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
Title
Conversation quality
Description
[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.
Time Frame
6 months
Title
Value proposition/Economic Impact
Description
[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
Title
Requirements
Description
Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]
Time Frame
6 months
Title
Affect
Description
[Interview] Feelings of enjoyment, satisfaction, when using the technology
Time Frame
6 months
Title
Participation Pattern
Description
How often system is used, buttons clicked, voice activation [usage data, interview, observations]
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Adams, PhD
Phone
770.290.0035
Email
aadams@simplec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jenay M Beer, PhD
Phone
404.308.4523
Email
jenay.beer@uga.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Adams, PhD
Organizational Affiliation
SimpleC, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jenay M Beer, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenay M Beer, PhD
Phone
404-308-4523
Email
jenay.beer@uga.edu
Facility Name
SimpleC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Adams, PhD
Phone
770-290-0035
Email
aadams@simplec.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SimpleC Wellness Platform With Social Robot Interaction (Long-term)

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