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Engagement, PatientNCT05599503

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

A study testing Behavioral Interventions and Robot Interventions in people with Engagement, Patient and Quality of Life, run by SimpleC, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Engagement, Patient, Quality of Life, Mood
What is being tested?
Behavioral Interventions and Robot Interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
2 sitesUnited States
Study dates
10 Aug 2022to 13 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Georgia

    Athens, Georgia, 30602

  • SimpleC

    Atlanta, Georgia, 30060

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Behavioral Interventions, Robot Interventions
Keywords
At risk, diagnosis
Medical subject headings
Patient Participation, Cognitive Dysfunction, Dementia, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral InterventionsBehavioural

    Traditional SimpleC Wellness

  • Robot InterventionsBehavioural

    Robot interventions

Study groups in NCT05599503
Study groupRoleWhat they receive
SimpleC Wellness Platform with Social Robot InteractionExperimentalParticipants 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).
Receives: Behavioral: Behavioral Interventions; Behavioral: Robot Interventions
SimpleC Wellness PlatformActive comparatorParticipants 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.
Receives: Behavioral: Behavioral Interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    [Questionnaire] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort

    Measured: Midpoint (3 months), Final (6 months)

  2. Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.

    [Questionnaire] Family caregiver feelings of guilt.

    Measured: Baseline, Midpoint (3 months), Final (6 months)

  3. Change in Perceived Stress Scale. A 5-point scale with higher scores indicating higher stress.

    [Questionnaire] Family caregiver experience of stress in the past 4 months. Modification: Answer as it relates to caregiving.

    Measured: Baseline, Midpoint (3 months), Final (6 months)

  4. Change in Technology Acceptance and Experience Questionnaire. A scale with high scores indicating higher acceptance.

    [Questionnaire] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.

    Measured: Midpoint (3 months), Final (6 months)

  5. Change in Quality of Life. A 13-item survey with high scores indicating higher quality of life.

    [Questionnaire] Assessment of different aspects of quality of life, including physical health, energy, family, money.

    Measured: Baseline, Midpoint (3 months), Final (6 months)

Secondary outcomes (8)

  1. Technology acceptance and adoption Interview.

    [Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.

    Measured: Midpoint (3 months)

  2. Technology acceptance and adoption Interview.

    [Interview] Assessment of users acceptance and adoption ease of use, usefulness, and satisfaction of using the technology.

    Measured: Final (6 months)

  3. Usability and usefulness

    Identified factors that indicate the ease of use and usefulness for different tasks as derived from analysis of: [Interview, usage data]

    Measured: 6 months

  4. Conversation quality

    [Interview] User perceptions on the usefulness and ease of use in conversing with the technology.

    Measured: 6 months

  5. Value proposition/Economic Impact

    [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.

    Measured: 6 months

  6. Requirements

    Identified requirements for design, training, and communication as derived from analysis of: [Interview, observations]

    Measured: 6 months

  7. Affect

    [Interview] Feelings of enjoyment, satisfaction, when using the technology

    Measured: 6 months

  8. Participation Pattern

    How often system is used, buttons clicked, voice activation [usage data, interview, observations]

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start10 Aug 2022
  3. Primary completion13 Nov 2023
  4. Study completion13 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599503
Sponsor's protocol ID
7645D
Status last verified
Mar 2024
First submitted
30 Aug 2022
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Interventions and Robot Interventions in people with Engagement, Patient and Quality of Life, run by SimpleC, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Midpoint (3 months), Final (6 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599503.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.

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