CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
HMD: Immersive VR +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04988360
NCT04988360N/ACompleted

VRx@Home: Pilot RCT to Evaluate the Effectiveness of Immersive Virtual Reality Therapy on People With Dementia Living at Home

University Health Network, Toronto·interventional·Posted Aug 3, 2021·Updated Oct 18, 2022

In Brief

A clinical study evaluating HMD: Immersive VR and Tablet: Non-immersive VR for Dementia. Completed, enrolled 7 participants across 2 sites.

Detailed Summary

The investigators are designing and rigorously evaluating the first Virtual Reality-therapy program for people with dementia (PwD) living at home, administered by their informal caregivers (family/friends). Virtual Reality (VR) presents a unique opportunity to transport people to a world outside of their confined spaces, into calming and stimulating settings (lush forest, peaceful beach, cheerful playground). Virtual Reality-therapy is a non-pharmacological approach that uses VR "experiences'' to stimulate brain function, improve psychological health, engage, and relax. It has potential to reduce symptoms of dementia such as apathy, depression, loneliness, sundowning, and the use of sedating medications with known negative side-effects. Caregivers of PwD are more likely to feel worried, tired, overwhelmed, and depressed than non-PwD caregivers. Symptoms of dementia and caregiver stress often result in early institutionalization of PwD; management of challenging symptoms may help PwD remain in their homes for longer while improving their, and their caregivers', Quality of Life (QoL). Addressing the wellbeing of caregivers is an often overlooked, yet integral part of interventions for PwD. It ensures intervention feasibility but also has a distinct impact on our system, reducing healthcare needs of caregivers and allowing them to continue contributing as caregivers. In this pilot study the investigators will train and assist caregivers to conduct Virtual Reality-therapy with their loved-ones at home using two devices: a head-mounted display and a tablet. This pilot study will assess: (1) the acceptability of the VR devices (2) feasibility of the study methods, (3) the impact of VR-therapy on PwD and caregiver outcomes. These findings will be used to inform a future randomized controlled trial (RCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia
CountriesCanada

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 3, 2021
Enrollment StartMay 10, 2022
Primary CompletionSep 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.9 years ago

Interventions

HMD: Immersive VRdevice

Participants with dementia will view 360-degree films using a commercially-available Virtual Reality head mounted display (HMD) that has built-in speakers. While wearing the HMD, participants with dementia will be able to visually explore the virtual environments by turning their head to face different directions. Caregivers-participants will take part in the VR experience concurrently by viewing a tablet that is connected to the HMD through the "screen mirroring" function.

Tablet: Non-immersive VRdevice

Participants with dementia will view 360-degree films on a commercially-available tablet that has built-in speakers. Participants with dementia will be able to visually explore the virtual environment using the touch screen (dragging the view around with one's finger). Caregiver-participants will take part in the VR experience concurrently by viewing the tablet while sitting or standing beside the participant with dementia.