- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06179225
Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37212-2010
- Vanderbilt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Nilanjan Sarkar, Vanderbilt University
Publications and helpful links
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 078480
- R21AG078480 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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