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

Quality of Life Clinical Trial

Official title:

Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05599503
• Other study ID #: 7645D
• Status: Completed
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: November 13, 2023

Study information

• Verified date: March 2024
• Source: SimpleC, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging Well
• Cognitive Change
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Engagement, Patient
• Mild Cognitive Impairment
• Mood
• Quality of Life

Intervention

Behavioral:
• Behavioral Interventions
Traditional SimpleC Wellness
• Robot Interventions
Robot interventions

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia
United States	SimpleC	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
SimpleC, LLC	Advanced Medical Electronics, University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Midpoint (3 months), Final (6 months)
Primary	Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.	[Questionnaire] Family caregiver feelings of guilt.	Baseline, Midpoint (3 months), Final (6 months)
Primary	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.	Baseline, Midpoint (3 months), Final (6 months)
Primary	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.	Midpoint (3 months), Final (6 months)
Primary	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.	Baseline, Midpoint (3 months), Final (6 months)
Secondary	Technology acceptance and adoption Interview.	[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.	Midpoint (3 months)
Secondary	Technology acceptance and adoption Interview.	[Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.	Final (6 months)
Secondary	Usability and usefulness	Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]	6 months
Secondary	Conversation quality	[Interview] User perceptions on the usefulness and ease of use in conversing with the technology.	6 months
Secondary	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.	6 months
Secondary	Requirements	Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]	6 months
Secondary	Affect	[Interview] Feelings of enjoyment, satisfaction, when using the technology	6 months
Secondary	Participation Pattern	How often system is used, buttons clicked, voice activation [usage data, interview, observations]	6 months