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

NCT05599503 | Completed

• 1 other identifier: 7645D
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

At risk, diagnosis

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (8)

• Technology acceptance and adoption Interview.

  Midpoint (3 months)

• Technology acceptance and adoption Interview.

  Final (6 months)

• Usability and usefulness

  6 months

• Conversation quality

  6 months

• Value proposition/Economic Impact

  6 months

Study Arms (2)

SimpleC Wellness Platform with Social Robot Interaction

EXPERIMENTAL

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

SimpleC Wellness Platform

ACTIVE COMPARATOR

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

Interventions

Behavioral Interventions BEHAVIORAL

Traditional SimpleC Wellness

SimpleC Wellness Platform; SimpleC Wellness Platform with Social Robot Interaction

Robot Interventions BEHAVIORAL

Robot interventions

SimpleC Wellness Platform with Social Robot Interaction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• Aged 18+ years
• Any gender
• Fluent in English
• Works for the Senior Housing Community

You may not qualify if:

• 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
• 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
• Expecting to move during the study (i.e., move out of facility)
• Both legally deaf and blind
• Pregnant

Sponsors & Collaborators

• Advanced Medical Electronics: collaborator
• SimpleC, LLC: lead
• University of Georgia: collaborator

Study Sites (2)

University of Georgia

Athens, Georgia, 30602, United States

Location

SimpleC

Atlanta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Patient Participation; Cognitive Dysfunction; Dementia; Disease

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anne Adams, PhD

  SimpleC, LLC

  PRINCIPAL INVESTIGATOR

• Jenay M Beer, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: October 31, 2022
• Study Start: August 10, 2022
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)