NCT06179225

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2025

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

December 2, 2023

Results QC Date

March 19, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

augmented reality; interactive communication technology; older adults; photorealistic avatars

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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.

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.

Behavioral: 2-D AV

Interventions

2-D AVBEHAVIORAL

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.

2-D Audio-Visual
HMD ARBEHAVIORAL

Older adults will wear head mounted display to engage in collaborative augmented reality activities: playing checkers, decorating a fireplace mantel.

HMD AR

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212-2010, United States

Location

Related Publications (1)

  • 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.

Limitations and Caveats

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.

Results Point of Contact

Title
Nilanjan Sarkar
Organization
Vanderbilt University

Study Officials

  • Nilanjan Sarkar

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Mechanical Engineering

Study Record Dates

First Submitted

December 2, 2023

First Posted

December 21, 2023

Study Start

April 22, 2024

Primary Completion

April 1, 2025

Study Completion

May 22, 2025

Last Updated

May 6, 2026

Results First Posted

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Upon publication of results. No end date.
Access Criteria
Researchers and scientists in the field can access by contacting Dr. Nilanjan Sarkar with a 1-2 page protocol.

Locations