Trial Outcomes & Findings for Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities (NCT NCT06179225)

Last Updated: 2026-05-06

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Week 4

Results posted on

2026-05-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	10	6
Overall Study COMPLETED	10	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analyses conducted by type of participant within each study arm: older adult or family member.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 4

Population: All participants completed the FIM questionnaire.

Outcome measures

Outcome measures
Measure	2-D Audio-Visual n=6 Participants 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.	HMD AR n=10 Participants 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.
Feasibility of Intervention Older Adult Participants	19.7 score on a scale Standard Deviation 0.6	18.0 score on a scale Standard Deviation 2.3
Feasibility of Intervention Family Participants	16.7 score on a scale Standard Deviation 2.9	16.2 score on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: Week 4

Population: Data were analyzed separtely for older adult participants and family participants.

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).

Outcome measures

Outcome measures
Measure	2-D Audio-Visual n=6 Participants 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.	HMD AR n=10 Participants 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.
Acceptability of Intervention Questionnaire Older adult participants	17.3 score on a scale Standard Deviation 2.3	17.0 score on a scale Standard Deviation 2.5
Acceptability of Intervention Questionnaire Family participants	18.3 score on a scale Standard Deviation 2.1	16.2 score on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: Baseline and week 4

Population: Analyses were conducted separately for older adults and for family participants.

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. .

Outcome measures

Outcome measures
Measure	2-D Audio-Visual n=6 Participants 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.	HMD AR n=10 Participants 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.
UCLA Loneliness Scale Older Adult Participants Baseline	12.7 score on a scale Standard Deviation 4.6	9.6 score on a scale Standard Deviation 2.6
UCLA Loneliness Scale Family Participants Baseline	15.3 score on a scale Standard Deviation 5.0	8.0 score on a scale Standard Deviation 3.1
UCLA Loneliness Scale Older Adults Week 4	11.7 score on a scale Standard Deviation 6.0	9.6 score on a scale Standard Deviation 4.6
UCLA Loneliness Scale Family Participants at Week 4	15.7 score on a scale Standard Deviation 6.5	9.4 score on a scale Standard Deviation 3.7

PRIMARY outcome

Timeframe: Week 4

Population: Older adults were analyzed separately from family members.

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.

Outcome measures

Outcome measures
Measure	2-D Audio-Visual n=6 Participants 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.	HMD AR n=10 Participants 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.
Networked Minds Measure (NMM) of Social Presence Older Adult Participants	2.3 units on a scale Standard Deviation 0.3	3.2 units on a scale Standard Deviation 0.4
Networked Minds Measure (NMM) of Social Presence Family Participants	2.2 units on a scale Standard Deviation 0.4	2.7 units on a scale Standard Deviation 0.7

Adverse Events

HMD AR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2-D Audio-Visual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nilanjan Sarkar

Vanderbilt University

Phone: 615-343-7219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	HMD AR n=10 Participants 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 n=6 Participants 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.	Total n=16 Participants Total of all reporting groups
Age, Continuous Older adult participants	71.4 Participant STANDARD_DEVIATION 6.3 • n=5 Participants • Analyses conducted by type of participant within each study arm: older adult or family member.	70.3 Participant STANDARD_DEVIATION 9.5 • n=3 Participants • Analyses conducted by type of participant within each study arm: older adult or family member.	71.0 Participant STANDARD_DEVIATION 6.9 • n=8 Participants • Analyses conducted by type of participant within each study arm: older adult or family member.
Age, Continuous Family participants	62.0 Participant STANDARD_DEVIATION 12.6 • n=5 Participants • Analyses conducted by type of participant within each study arm: older adult or family member.	59.0 Participant STANDARD_DEVIATION 25.6 • n=3 Participants • Analyses conducted by type of participant within each study arm: older adult or family member.	60.9 Participant STANDARD_DEVIATION 16.8 • n=8 Participants • Analyses conducted by type of participant within each study arm: older adult or family member.
Sex: Female, Male Female	10 Participants n=10 Participants • All participants in both arms were female. Provided the overall total.	6 Participants n=6 Participants • All participants in both arms were female. Provided the overall total.	16 Participants n=16 Participants • All participants in both arms were female. Provided the overall total.
Sex: Female, Male Male	0 Participants n=10 Participants • All participants in both arms were female. Provided the overall total.	0 Participants n=6 Participants • All participants in both arms were female. Provided the overall total.	0 Participants n=16 Participants • All participants in both arms were female. Provided the overall total.
Race (NIH/OMB) Older adults · American Indian or Alaska Native	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Older adults · Asian	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Older adults · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Older adults · Black or African American	3 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	1 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	4 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Older adults · White	2 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	2 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	4 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Older adults · More than one race	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Older adults · Unknown or Not Reported	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Family members · American Indian or Alaska Native	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Family members · Asian	1 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	1 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Family members · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Family members · Black or African American	3 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	1 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	4 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Family members · White	1 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	1 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	2 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Family members · More than one race	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	0 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Race (NIH/OMB) Family members · Unknown or Not Reported	0 Participants n=5 Participants • Analyses provided by type of participant: older adult or family.	1 Participants n=3 Participants • Analyses provided by type of participant: older adult or family.	1 Participants n=8 Participants • Analyses provided by type of participant: older adult or family.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=6 Participants	0 Participants n=16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=10 Participants	6 Participants n=6 Participants	16 Participants n=16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=6 Participants	0 Participants n=16 Participants
Region of Enrollment United States	10 Participants n=10 Participants	6 Participants n=6 Participants	16 Participants n=16 Participants
Loneliness Older adults	9.6 Participant STANDARD_DEVIATION 2.6 • n=5 Participants • 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.	12.7 Participant STANDARD_DEVIATION 4.6 • n=3 Participants • 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.	10.8 Participant STANDARD_DEVIATION 3.5 • n=8 Participants • 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.
Loneliness Family Participants	8.0 Participant STANDARD_DEVIATION 3.1 • n=5 Participants • 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.	15.3 Participant STANDARD_DEVIATION 5.0 • n=3 Participants • 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.	10.8 Participant STANDARD_DEVIATION 5.2 • n=8 Participants • 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.