Robot for Alleviating Loneliness and Engaging Nursing Home Residents

December 15, 2023 updated by: Northeastern University

Autonomous Navigating Telepresence Robot for Alleviating Loneliness and Engaging Nursing Home Residents With and Without Dementia

Social isolation is an emerging critical challenge in the care of older adults. Nursing home residents engage for an average of just 12 minutes per day with an activity director, a situation further exacerbated by Covid-19. Social isolation has detrimental effects on health, evidenced by 48.7% of nursing home residents with an active depression diagnosis, and 61% have moderate or severe cognitive impairment. The ultimate goal of this project is to alleviate older adults loneliness and boredom and to improve their mood in an economically feasible and scalable way. The investigators will integrate the existing Vigorous Mind (VM) multidomain activities platform for older adults with an affordable autonomous navigating robot to remotely socialize with and engage long-term-care facility (Facility) residents diagnosed with Mild Cognitive Impairment (MCI) or early-stage Alzheimer s disease or related dementias (Residents). The VM web-based platform has been used for group activities in senior living facilities for eight years. A Resident s profile in VM automatically searches the web and presents their favorite music, reminiscence content, comedy, and personalized brain exercises. VM is secure and HIPAA compliant. A VM employee (VM Companion) with experience running activities in a long-term care facility will be introduced by the staff to a Resident as a new companion who will visit the Resident through the robot to keep them company. The temi robot can be instructed to go to room 312 and it will navigate its way to the room. The Resident will be notified that the VM Companion is arriving for a visit, and once in the room, the VM Companion will see and greet the Resident, and the Resident will see the VM Companion. Since the VM Companion has dashboard access to the Resident s background and interests via the VM profile, they will be able to meaningfully socialize and engage in relevant VM activities. The goal of this Phase I project is to test the feasibility of this idea and to collect preliminary data on its effect on loneliness and mood.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background:

Social isolation and loneliness are critical challenges in older adult care. Loneliness is associated with declines in both physical and mental health. Approximately 50% of older adults over the age of 80 years experience loneliness. Nursing home residents are at a greater risk of loneliness due to limited staffing and COVID-19 visiting restrictions in place. More socially active older adults experience less cognitive decline in old age and better overall functioning. The use of technology for social interaction may have a positive impact on the behavioral and psychological symptoms of Alzheimer's disease (AD) especially in early stages of the disease. Robots are currently used in very few senior living facilities and cognitive support and communication are among the most desired functions. By using an autonomous navigating telepresence robot, the intervention brings the technology to the resident and allows her/him to socialize and interact with a loved-one without the need for a caregiver. This intervention integrates the Vigorous Mind system with the temi autonomous navigating telepresence robot (Vigorous Mind Robot - "VMR").

Aims:

  1. Develop web-based visit scheduler and integrate the VM platform with the temi robot
  2. Test usability of the VMR with 10 Residents and family members
  3. Pilot study of the feasibility of a VMR intervention with 40 Residents

Experimental Design:

Testing of the VMR intervention consisted of a usability and feasibility phase. During usability, residents and family members were trained on use of the VMR robot and web-interface. Family members conducted two virtual visits and usability interviews with residents and family members followed each visit. Feasibility followed usability testing with a three-month period where family members were able to schedule virtual visits as often as they would like. Debriefing interviews with family members and residents occurred at the end of feasibility testing. Resident loneliness and mood was assessed with the UCLA Loneliness Scale, Geriatric Depression Scale, single-item loneliness scale, and PHQ-2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Dedham, Massachusetts, United States, 02026
        • New Bridge on the Charles
      • Weston, Massachusetts, United States, 02493
        • Maplewood Senior Living

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Residents of 2 nursing homes in Massachusetts

Description

Inclusion Criteria:

  • Over 65 years of age
  • Able to read and speak English
  • Recommended by staff or family member

Exclusion Criteria:

  • Uncorrected vision or auditory impairment
  • MoCA < 22

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall experience with the robot - for the family
Time Frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
3 months
Overall experience with the robot for the resident
Time Frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
3 months
Ease of use of the robot for the family
Time Frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
3 months
Ease of use of the robot for the resident
Time Frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Loneliness of resident
Time Frame: 3 months
5 point rating from minimum of "seldom/never" to maximum of "always/often"; change over 3 months
3 months
Change in depression level of resident
Time Frame: 3 months
Change in PHQ-2 score over 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northeastern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vigorous Mind, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R43AG073004-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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