NCT05296239

Brief Summary

This implementation 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

February 23, 2022

Results QC Date

August 7, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

At riskDiagnosis

Outcome Measures

Primary Outcomes (2)

  • Facilitators to Successful Implementation

    \[Interview\] Identified factors that facilitate successful implementation (e.g., WiFi, environmental set up, user perceptions) as derived from analysis of interview. A content analysis of the qualitative data was conducted. This identified themes, such as usefulness or engagement. We report the frequency of each theme mentioned during the interview.

    3 weeks

  • Barriers to Successful Implementation

    \[Interview\] Identified factors that are barriers to implementation (e.g., WiFi, environmental set up, user perceptions) as derived from interview. A content analysis of the qualitative data was conducted. This identified themes, such as technology or hard to use. We report the frequency of each theme mentioned during the interview.

    3 weeks

Secondary Outcomes (11)

  • Technology Acceptance Model Questionnaire. A 12-item Scale (1-7) With High Scores Indicating Higher Acceptance.

    3 weeks

  • Technology Acceptance and Adoption

    3 weeks

  • Robotic Social Attributes Scale (RoSAS): Family & Staff

    3 weeks

  • Robotic Social Attributes Scale (RoSAS): Residents

    3 weeks

  • Robot Social Attributes

    3 weeks

  • +6 more secondary outcomes

Study Arms (1)

SimpleC Wellness Platform with Social Robot Interaction

EXPERIMENTAL

Three participant groups: Residents, family members, and staff

Other: SimpleC Wellness Platform with Social Robot Interaction

Interventions

Once respondents enroll, they will receive the SimpleC Wellness Platform, including introduction training on the SAR system. During the study period, participants and others will receive instructions for the SAR system and use it as part of scheduled interactions, which includes interactions as part of the general schedule. In the third week, the social robot will be installed, and staff trained in group sessions as available. Participants may use the full SAR system as they are willing. Interactions specific to the virtual and physical robot include notifications to join activities as per community schedule as well as trivia.

SimpleC Wellness Platform with Social Robot Interaction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All: Fluent in English
  • Resident: 50 years and older
  • Resident: lives in Assisted Living Community
  • Resident: MMSE score of 13 or higher
  • Family member: 18 years and older
  • Family member: family or friend of resident
  • Family member: no diagnosis of dementia or related disorder
  • Staff: 18 years and older
  • Staff: works for the Senior Housing Community

You may not qualify if:

  • All: pregnant
  • Resident: Expecting to move during the study
  • Resident: Both legally deaf and blind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Georgia

Athens, Georgia, 30602, United States

Location

SimpleC, LLC

Atlanta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Patient ParticipationCognitive DysfunctionDementiaDisease

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorCognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

We experienced SARS-COV-2 related restrictions in availability, flexibility, and access to community, staff, and residents.

Results Point of Contact

Title
Dr. Anne Adams
Organization
SimpleC LLC

Study Officials

  • Anne Adams, PhD

    SimpleC, LLC

    PRINCIPAL INVESTIGATOR
  • Jenay Beer, PhD

    jenay.beer@uga.edu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 25, 2022

Study Start

February 3, 2022

Primary Completion

March 7, 2022

Study Completion

March 7, 2022

Last Updated

March 5, 2026

Results First Posted

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations