Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities

May 4, 2026 updated by: Nilanjan Sarkar, Vanderbilt University
The goal of this clinical trial is to test the use of head-mounted display (HMD) augmented reality (AR) in older adults residing in communities or assisted care facilities. The main questions it aims to answer are: what is the feasibility, acceptability, and satisfaction of HMD AR vs two-dimensional audio-video communication? Older adults and their designated family member will complete HMD AR activities in 8 session visits over 4 weeks. Researchers will compare HMD AR to 2-D audio-visual (AV) comparison group on feasibility, acceptability, and satisfaction with the interactive communication technology.

Study Overview

Status

Completed

Conditions

Detailed Description

For both interventions, the bandwidth within the participants' homes will be measured and a hotspot created if necessary to facilitate data streaming. For each session, a trained research assistant (RA) will be physically present at the participants' homes to troubleshoot for technological issues. The RA will observe the participant establish the Interactive Communication technology (ICT) connection, assisting as needed. The RA will remain within the room; the RA will monitor for technological issues and participants' reactions.

HMD-AR Intervention Experimental Setup. Equipment includes a Kinect camera (Microsoft Corporation), a microphone, an HMD, and a laptop on which the data sharing and the activity ran and remotely displayed on the participant's HMD. The RA ensured that the participants were connected before moving to an unobtrusive viewing area. Upon completion of the session, the RA dismantled all equipment and cleaned the HMD with disinfectant wipes.

AR Activities. Two collaborative AR activities were available tot he participants: fireplace decoration and checkers. If the fireplace activity was selected, participants could choose from a variety of virtual objects to decorate the fireplace mantel, hearth, or nearby wall. For the checkers activity, each participant sat at a table, and the checkerboard and checkers appeared as a virtual object in space. Participants were able to see each other's photorealistic avatars during both activities. Upon completion of each session, the participants would let the RAs know who turned off the AR display and stopped the data communication. Before the start of the experimental sessions, RAs provided one-on-one training and orientation to the HMD-AR to ensure that the participants were able to navigate the system. In addition, a hard-copy, 1-page quick reference guide was provided to each participant. Each older adult-companion pair participated in 2 sessions per week for 4 weeks (total of 8 sessions).

Creation of photorealistic avatars. A mobile app, Polycam, was used to take multiple photos of the participant's face using a 360-degree view. Polycam constructed a 3D model from these photos that was then used to create a MetaHuman on Unreal Engine, matching the facial geometry and the facial features of the participant. However, MetaHuman Creator is limited in its ability to match the features exactly; therefore, the RAs added manual touch-ups to ensure the avatar looked similar to the participant. After creating the first version of the avatar, a video call was arranged with the participants to share their avatar with them and receive feedback. Participants were able to pick their avatar's clothing, hair, body shape, and accessories, and apply makeup. If a participant was not satisfied with the likeness of their avatar, the process was repeated, and more manual touch-ups were added. A second meeting was arranged with the participants to share the new version.

2D Audio-visual Intervention The 2D audio-visual sessions will take place in a dedicated room at the assisted living facility and in an area of the participants' choice for those living at home. RA will initiate the connection between the older adult and family member. In the unlikely event a family member does not have a device for the 2D audio-visual visits, a computer tablet will be supplied for use during the study. Upon completion of the session, the RAs recovered any loaned devices.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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

    • Tennessee
      • Nashville, Tennessee, United States, 37212-2010
        • Vanderbilt University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 60 and older
  • residing at home in community
  • if residing in assisted living facility, more than 3 months

Exclusion Criteria:

  • unable to provide assent or consent
  • unable to understand or speak English
  • physical impairment that impedes participation
  • terminally ill

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HMD AR
Pairs of older adults with their designated family members who geographically apart will perform collaborative activities using HMD AR in 8 sessions over 4 weeks.
Older adults will wear head mounted display to engage in collaborative augmented reality activities: playing checkers, decorating a fireplace mantel.
Active Comparator: 2-D Audio-Visual
Pairs of older adults with their designated family members who geographically apart will perform collaborative activities using 2-D Audio-Visual in 8 sessions over 4 weeks.
Older adults will use 2-D AV to engage with family members at a distance. Links will be provided to play a game of checkers or decorate a fireplace setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention
Time Frame: Week 4
Feasibility of Intervention Measure (FIM) questionnaire is valid 4-item questionnaire that respondents answer from 1 (completely disagree) to 5 (completely agree) on whether the intervention seems implementable, possible, doable, and easy to use. Range of scores are 4 (least feasible) to 20 (greatest feasibility).
Week 4
Acceptability of Intervention Questionnaire
Time Frame: Week 4
The degree to which the technology is acceptable to older adults and their family members. The Acceptability of Intervention Measure (AIM) was used. This is a valid instrument consisting of 4 items that participants indicate the level of acceptability on a 5-point scale ranging from 1 (completely disagree) to 5 (completely agree). Concepts are meets approval, is appealing, like, and welcome. Range of total scores is 4 (least acceptable) to 20 (most acceptable).
Week 4
UCLA Loneliness Scale
Time Frame: Baseline and week 4
Measure of loneliness of older adults and of family participants at baseline using the UCLA-6 Loneliness Scale. This valid instrument consists of 6 items in which the participant indicates the frequency of the loneliness symptoms from 1 (never) to 4 (always). Range of total score is 6-24 with higher values indicating greater loneliness. .
Baseline and week 4
Networked Minds Measure (NMM) of Social Presence
Time Frame: Week 4
At the last session, participants completed the Networked Minds Measure of Social Presence instrument, that assesses the participant's perception of their awareness of the other person, whether the other person seems to pay attention, whether emotional aspects were conveyed and how well they could understand the other person during the interaction. The total score ranges from 0 to 4 with higher scores indicating greater social presence with the interactive communication technology.
Week 4

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Nilanjan Sarkar, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

April 22, 2024

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

May 22, 2025

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 078480
  • R21AG078480 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be provided upon request to the principal investigator. Data includes participant demographics, covariates, outcome data.

IPD Sharing Time Frame

Upon publication of results. No end date.

IPD Sharing Access Criteria

Researchers and scientists in the field can access by contacting Dr. Nilanjan Sarkar with a 1-2 page protocol.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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