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

NCT ID: NCT05599503

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2023-11-13

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SimpleC Wellness Platform with Social Robot Interaction

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).

Group Type EXPERIMENTAL

Behavioral Interventions

Intervention Type BEHAVIORAL

Traditional SimpleC Wellness

Robot Interventions

Intervention Type BEHAVIORAL

Robot interventions

SimpleC Wellness Platform

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.

Group Type ACTIVE_COMPARATOR

Behavioral Interventions

Intervention Type BEHAVIORAL

Traditional SimpleC Wellness

Interventions

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Behavioral Interventions

Traditional SimpleC Wellness

Intervention Type BEHAVIORAL

Robot Interventions

Robot interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)


* 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
* New or current user of SimpleC

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Georgia

OTHER

Sponsor Role collaborator

Advanced Medical Electronics

OTHER

Sponsor Role collaborator

SimpleC, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

SimpleC, LLC

Jenay M Beer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

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University of Georgia

Athens, Georgia, United States

Site Status

SimpleC

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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7645D

Identifier Type: -

Identifier Source: org_study_id

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