Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06174337 |
| Other study ID # |
1R43AG073004-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 21, 2022 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Northeastern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
