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

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179225
• Other study ID #: 078480
• Secondary ID: R21AG078480
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Vanderbilt University
• Contact: Kelley J. Colopietro, BS
• Phone: 615-936-0461
• Email: kelley.j.colopietro[@]vanderbilt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 long term care communities. 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.

Description:

For both interventions, the bandwidth within the family members' 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 Long-term Care (LTC) to troubleshoot for technological issues. The RA will observe the staff member establish the Interactive Communication technology (ICT) connection between the older adult and family member, assisting as needed. The RA and staff member will remain within the room; the RA will monitor for technological issues. The staff member will monitor the older adults' reactions.

HMD-AR Intervention Experimental Setup. For the older adults, equipment set-up will be in a dedicated room at the LTC that allows for environmental overlays. Equipment includes two Kinect cameras, one HMD and one E4 wrist sensor that the older adult will wear to measure stress through physiological sensing. The family member will be consulted for placement of the 2 Kinect cameras in their home.

AR Activities. At least one meal session and one activity session will be conducted. The remaining sessions will consist of activities based on the preference of the older adult-family member. Staff will be trained to turn on the headset, computers, and ensure communication connection between the older adult and family member.

2D Audio-visual Intervention The 2D audio-visual sessions will take place in a dedicated room at the LTC. Staff 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• age 60 and older

• residing at LTC greater than 3 months

Exclusion Criteria:

• unable to provide assent or consent

• unable to understand or speak English

• physical impairment that impedes participation

• terminally ill

Related Conditions & MeSH terms

• Loneliness

Intervention

Behavioral:
• HMD AR
Older adults will wear head mounted display to engage in collaborative augmented reality activities: sharing a meal, playing board games, and decorating home.
• 2-D AV
Older adults will use 2-D AV to engage with family members at a distance.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention Measure (FIM) questionnaire	questionnaire	Week 4
Primary	Acceptability of Intervention Measure (AIM)	The degree to which the technology is acceptable to older adults and their family members.	Week 4
Primary	UCLA Loneliness Scale	Measure of loneliness of older adults	Baseline and week 4
Primary	Networked Minds Measure (NMM) of Social Presence	Measure of Social Presence, which is the psychological phenomenon in which others are perceived as physical 'real' persons in ICT	Week 4