Clinical trial NCT05599503: SimpleC Wellness Platform With Social Robot Interaction (Long-term)
Official title: Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Engagement, Patient
Quality of Life
Mood
Aging Well
Cognitive Change
Mild Cognitive Impairment
Cognitive Impairment
Dementia
Keywords: At risk, diagnosis
Lead sponsor: SimpleC, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Georgia
name: Advanced Medical Electronics
First posted: 2022-10-31
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 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
* Pregnant

Staff Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: Midpoint (3 months), Final (6 months)
measure: Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.
timeFrame: Baseline, Midpoint (3 months), Final (6 months)
measure: Change in Perceived Stress Scale. A 5-point scale with higher scores indicating higher stress.
timeFrame: Baseline, Midpoint (3 months), Final (6 months)
measure: Change in Technology Acceptance and Experience Questionnaire. A scale with high scores indicating higher acceptance.
timeFrame: Midpoint (3 months), Final (6 months)
measure: Change in Quality of Life. A 13-item survey with high scores indicating higher quality of life.
timeFrame: Baseline, Midpoint (3 months), Final (6 months)
Secondary outcomes:
measure: Technology acceptance and adoption Interview.
timeFrame: Midpoint (3 months)
measure: Technology acceptance and adoption Interview.
timeFrame: Final (6 months)
measure: Usability and usefulness
timeFrame: 6 months
measure: Conversation quality
timeFrame: 6 months
measure: Value proposition/Economic Impact
timeFrame: 6 months
measure: Requirements
timeFrame: 6 months
measure: Affect
timeFrame: 6 months
measure: Participation Pattern
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
city: Atlanta
country: United States
facility: SimpleC
state: Georgia
Study officials:
affiliation: SimpleC, LLC
name: Anne Adams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Georgia
name: Jenay M Beer, PhD
role: PRINCIPAL_INVESTIGATOR
References: