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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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date November 30, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Use of Video Connection with Family via Robot
A remote family member is able to connect via video with a nursing home resident.

Locations

Country Name City State
United States New Bridge on the Charles Dedham Massachusetts
United States Maplewood Senior Living Weston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Northeastern University Vigorous Mind, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall experience with the robot - for the family 5 point Likert scale from maximum of "very good" to minimum of "very poor" 3 months
Primary Overall experience with the robot for the resident 5 point Likert scale from maximum of "very good" to minimum of "very poor" 3 months
Primary 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
Primary 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 Change in Loneliness of resident 5 point rating from minimum of "seldom/never" to maximum of "always/often"; change over 3 months 3 months
Secondary Change in depression level of resident Change in PHQ-2 score over 3 months 3 months
See also
  Status Clinical Trial Phase
Completed NCT04142645 - OptiMEDs Pilot Study N/A
Recruiting NCT05658666 - Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.