LonelinessNCT06179225
Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities
A study testing HMD AR and 2-D AV in people with Loneliness, run by Vanderbilt University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- HMD AR and 2-D AV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 22 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 60 and older
- residing at home in community
- if residing in assisted living facility, more than 3 months
Who cannot join
- unable to provide assent or consent
- unable to understand or speak English
- physical impairment that impedes participation
- terminally ill
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University
Nashville, Tennessee, 37212-2010
About this study
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.
Read the 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.
- Conditions
- Loneliness
- Being tested
- HMD AR, 2-D AV
- Keywords
- augmented reality; interactive communication technology; older adults; photorealistic avatars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMD ARBehavioural
Older adults will wear head mounted display to engage in collaborative augmented reality activities: playing checkers, decorating a fireplace mantel.
2-D AVBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HMD AR | Experimental | 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. Receives: Behavioral: HMD AR |
| 2-D Audio-Visual | Active comparator | 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. Receives: Behavioral: 2-D AV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
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).
Measured: Week 4
Acceptability of Intervention Questionnaire
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).
Measured: Week 4
UCLA Loneliness Scale
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. .
Measured: Baseline and week 4
Networked Minds Measure (NMM) of Social Presence
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start22 Apr 2024
- Primary completion1 Apr 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nilanjan Sarkar, Vanderbilt University
- Investigators
- Nilanjan Sarkar, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179225
- Sponsor's protocol ID
- 078480
- Other IDs
- R21AG078480
- Status last verified
- May 2026
- First submitted
- 2 Dec 2023
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be provided upon request to the principal investigator. Data includes participant demographics, covariates, outcome data.
Publications
Sarkar N, Tate JA, Tauseef M, Ullal A, Maxwell CA, Juckett LA, Scharre DW, Tan A, Zhang R, Ingram Z, Mion LC. Feasibility and Acceptability of Collaborative Augmented Reality for Older Adults and Companions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 11;15:e83864. doi: 10.2196/83864.
PubMed 41672493
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities
- ClinicalTrials.gov ID
- NCT06179225
- Acronym / sponsor ID
- 078480
- Conditions
- Loneliness
- Keywords
- augmented reality; interactive communication technology; older adults; photorealistic avatars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMD AR | Experimental | Behavioral: HMD ARPairs of older adults with their designated family members who geographically apart will perform collaborative activities using HMD AR in 8 sessions over 4 weeks. |
| 2-D Audio-Visual | Active comparator | Behavioral: 2-D AVPairs 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60 and older
- residing at home in community
- if residing in assisted living facility, more than 3 months
Key exclusion criteria (4 listed)
- unable to provide assent or consent
- unable to understand or speak English
- physical impairment that impedes participation
- terminally ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMD AROlder adults will wear head mounted display to engage in collaborative augmented reality activities: playing checkers, decorating a fireplace mantel. | Behavioural | HMD AR |
| 2-D AVOlder 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. | Behavioural | 2-D Audio-Visual |
Primary outcome
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).
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).
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. .
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41672493Sarkar N, Tate JA, Tauseef M, Ullal A, Maxwell CA, Juckett LA, Scharre DW, Tan A, Zhang R, Ingram Z, Mion LC. Feasibility and Acceptability of Collaborative Augmented Reality for Older Adults and Companions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 11;15:e83864. doi: 10.2196/83864.
- Individual participant dataSharing planned: Yes. De-identified data will be provided upon request to the principal investigator. Data includes participant demographics, covariates, outcome data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilanjan Sarkar principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMD AR and 2-D AV in people with Loneliness, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention (time frame: Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.