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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05599503
Enrollment
63
Registered
2022-10-31
Start date
2022-08-10
Completion date
2023-11-13
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

At risk, diagnosis

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.

Interventions

Traditional SimpleC Wellness

BEHAVIORALRobot Interventions

Robot interventions

Sponsors

University of Georgia
CollaboratorOTHER
Advanced Medical Electronics
CollaboratorOTHER
SimpleC, LLC
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
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.Midpoint (3 months), Final (6 months)\[Questionnaire\] 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.Baseline, Midpoint (3 months), Final (6 months)\[Questionnaire\] Family caregiver feelings of guilt.
Change in Perceived Stress Scale. A 5-point scale with higher scores indicating higher stress.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.Midpoint (3 months), Final (6 months)\[Questionnaire\] 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.Baseline, Midpoint (3 months), Final (6 months)\[Questionnaire\] Assessment of different aspects of quality of life, including physical health, energy, family, money.

Secondary

MeasureTime frameDescription
Technology acceptance and adoption Interview.Midpoint (3 months)\[Interview\] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.
Usability and usefulness6 monthsIdentified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: \[Interview, usage data\]
Conversation quality6 months\[Interview\] User perceptions on the usefulness and ease of use in conversing with the technology.
Value proposition/Economic Impact6 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.
Requirements6 monthsIdentified requirements for design, training, and communication as derived from analysis of: \[Interview, observations\]
Affect6 months\[Interview\] Feelings of enjoyment, satisfaction, when using the technology
Participation Pattern6 monthsHow often system is used, buttons clicked, voice activation \[usage data, interview, observations\]

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026