NCT06174337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

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

June 21, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

December 4, 2023

Last Update Submit

December 15, 2023

Conditions

Keywords

RobotLonelinessNursing Home

Outcome Measures

Primary Outcomes (4)

  • Overall experience with the robot - for the family

    5 point Likert scale from maximum of "very good" to minimum of "very poor"

    3 months

  • Overall experience with the robot for the resident

    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

    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

    5 point Likert scale from maximum of "very good" to minimum of "very poor"

    3 months

Secondary Outcomes (2)

  • Change in Loneliness of resident

    3 months

  • Change in depression level of resident

    3 months

Interventions

A remote family member is able to connect via video with a nursing home resident.

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of 2 nursing homes in Massachusetts

You may qualify if:

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

You may not qualify if:

  • Uncorrected vision or auditory impairment
  • MoCA \< 22

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New Bridge on the Charles

Dedham, Massachusetts, 02026, United States

Location

Maplewood Senior Living

Weston, Massachusetts, 02493, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 18, 2023

Study Start

June 21, 2022

Primary Completion

August 1, 2023

Study Completion

November 30, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations