Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AG078480 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMD AR | Behavioral | Older adults will wear head mounted display to engage in collaborative augmented reality activities: playing checkers, decorating a fireplace mantel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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. . | 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. | Week 4 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nilanjan Sarkar | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37212-2010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41672493 | Derived | 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. |
Not provided
Not provided
De-identified data will be provided upon request to the principal investigator. Data includes participant demographics, covariates, outcome data.
Upon publication of results. No end date.
Researchers and scientists in the field can access by contacting Dr. Nilanjan Sarkar with a 1-2 page protocol.
Not provided
Not provided
138 adults were approached. 25 individuals consented to be screened for eligibility. 16 individuals (8 pairs) met all eligibility criteria and were randomized to treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The overall number of participants 10 (5 older adullts with 5 designated family members) in the HMD AR arm and 6 (3 older adults with 3 designated family members) in the 2-D Audio Visual Arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 2-D Audio-Visual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are analyzed separately for the two types of participants within each arm: older adults and family members. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All participants completed the FIM questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
From enrollment until end of follow-up, up to 6 weeks.
Data were collected through direct observation and query.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
This was a small feasibility pilot with the main focus on older adult and family participants acceptance of the HMD-AR or Zoom as an interactive communication technology. Given the small sample size, no conclusions can be made on whether HMD-AR or Zoom is effective in decreasing loneliness. Larger trials for longer duration are necessary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nilanjan Sarkar | Vanderbilt University | 615-343-7219 | nilanjan.sarkar@vanderbilt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2023 | Apr 13, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2024 | Aug 15, 2025 | ICF_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2-D AV | Behavioral | 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. |
|
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.
| BG002 | Total | Total of all reporting groups |
Analyses conducted by type of participant within each study arm: older adult or family member. |
| Mean |
| Standard Deviation |
| Participant |
|
| Sex: Female, Male | All participants in both arms were female. Provided the overall total. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Analyses provided by type of participant: older adult or family. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | All participants were from the general Nashville, TN area | Count of Participants | Participants |
|
| Loneliness | UCLA-6 Loneliness Scale was used to collect baseline measure of loneliness for older adults and for families. | Analyses are conducted for each type of participant, older adult or family member, for each study condition, HMD-AR or 2-D audio-visual communication. | Mean | Standard Deviation | Participant |
|
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.
|
|
| Primary | 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). | Data were analyzed separtely for older adult participants and family participants. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| Primary | 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. . | Analyses were conducted separately for older adults and for family participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline and week 4 |
|
|
|
| Primary | 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. | Older adults were analyzed separately from family members. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Family participants |
|
|
| Family Participants Baseline |
|
|
| Older Adults Week 4 |
|
|
| Family Participants at Week 4 |
|
|
| Family Participants |
|
|