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Clinical Trials/NCT05599503
NCT05599503
Completed
N/A

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

SimpleC, LLC2 sites in 1 country63 target enrollmentAugust 10, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Engagement, Patient
Sponsor
SimpleC, LLC
Enrollment
63
Locations
2
Primary Endpoint
Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2022
End Date
November 13, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
SimpleC, LLC
Responsible Party
Sponsor

Eligibility Criteria

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

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
  • 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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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

Secondary Outcomes

  • Requirements(6 months)
  • Usability and usefulness(6 months)
  • Participation Pattern(6 months)
  • Technology acceptance and adoption Interview.(Final (6 months))
  • Conversation quality(6 months)
  • Value proposition/Economic Impact(6 months)
  • Affect(6 months)

Study Sites (2)

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