- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06174337
Robot for Alleviating Loneliness and Engaging Nursing Home Residents
Autonomous Navigating Telepresence Robot for Alleviating Loneliness and Engaging Nursing Home Residents With and Without Dementia
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Develop web-based visit scheduler and integrate the VM platform with the temi robot
- Test usability of the VMR with 10 Residents and family members
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Massachusetts
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Dedham, Massachusetts, United States, 02026
- New Bridge on the Charles
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Weston, Massachusetts, United States, 02493
- Maplewood Senior Living
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R43AG073004-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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