Clinical trial NCT04988360: VRx@Home: Study to Evaluate VR-therapy for PwD Living at Home
Official title: VRx@Home: Pilot RCT to Evaluate the Effectiveness of Immersive Virtual Reality Therapy on People With Dementia Living at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Virtual Reality
Tablets
Interpersonal Relations
Community Health Services
Apathy
Depressive Symptoms
Behavioral Symptoms
Quality of Life
Caregivers
Spouse Caregivers
Family Caregivers
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Centre for Aging and Brain Health Innovation
First posted: 2021-08-03
Enrollment: 7
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: This pilot trial will be a mixed-methods, parallel arm RCT with a target total recruitment of 30 participants (15 dyads of PwD and caregivers). Each dyad will participate in the study for a total of 4 weeks.

After obtaining informed consent, the research coordinator will set up a time convenient to both parties (the researcher and participant dyad) to conduct a baseline semi-structured interview that collects demographics as well as a questionnaire consisting of validated instruments on the outcome measures of interest (e.g. quality of life, apathy, etc.) Once baselines data collection is complete, the dyad will be randomized into one of two study arms, determining which VR technology they will be using first: (A) HMD first (immersive VR), or (B) Tablet first (non-immersive VR). Those assigned to Group A will use the HMD for weeks 1-2 and the tablet for weeks 3-4. Those assigned to Group B will use the tablet for weeks 1-2 and the HMD for weeks 3-4. After randomization, the participants, caregivers, and research personnel will not be blind to treatment allocation given the nature of the interventions.

The benefits of this randomized crossover design include the: (1) ability to compare the outcomes between immersive VR (HMD system) and non-immersive VR (tablet-only system) where each dyad serves as their own control, reducing the effects of inter-individual variability or disease progression, (2) opportunity for all participants to use the VR HMD, and (3) ability to explore whether the intervention "washes-out" soon after each therapy period or if it has a carryover effect.

Irrespective of experimental arm (Group A or Group B), the intervention consists of therapy sessions administered five times per week, at times agreeable to the dyad, for a total of approximately 80 minutes per week (20 minutes per viewing, 4 times per week). Prior to each session, the caregiver-participant will commence video-recording via the video-conferencing application (as taught during the training session). Once the recording is confirmed, the participants may start their session. During each session, PwD should be seated in a comfortable and secure chair of their choice. Caregiver-participants will help PwD equip the device and launch the films. The participant dyad will be able to select from a wide range of films available on each device. Once the selected film starts to play, the caregiver-participant will be seated nearby to ensure the safety of the PwD and to jointly experience VR. Once the dyad has finished using VR and their discussions/interactions about VR have concluded, the caregiver-participant may stop the video recording. The video recording will be stored securely automatically. Each member of the study dyad will then complete a personal reflection about the study session.

In addition to the video-recording (used to analyze participant interaction and conduct conversation analysis) some data collection tools are meant to be filled in after each session. The remaining data is collected via a structured questionnaire containing validated instruments and open-ended questions filled in at Baseline (T0), at the end of Weeks 1-2 (T1), and at the end of Weeks 3-4 (T2), to gather experiences using both the VR and tablet devices, and potential impact on clinical outcomes. The usability of each VR technology will be assessed at the end of T1 and T2.

Eligibility criteria: PwD inclusion criteria:

* Individuals who are 65 years of age or older.
* Individuals living at home with a family caregiver.
* Individuals diagnosed with mild to moderate dementia.

PwD exclusion criteria:

* Individuals with open wounds on face (sutured lacerations exempted).
* Individuals with a history of seizures or epilepsy.
* Individuals with a pacemaker.
* Individuals with head trauma or stroke leading to their current admission.
* Individuals with cervical conditions or injuries that would make it unsafe for them to use the VR headset.
* Individuals with alcohol related dementia/ Korsakoff syndrome.
* Individuals who have a Public Guardian and Trustee (PGT) as Substitute Decision Maker (SDM).
* Individuals who cannot speak and understand English

Caregiver inclusion criteria:

* Live with a PwD
* Identify as a primary caregiver for the PwD

Caregiver exclusion criteria:

* Individuals who cannot speak and understand English
* Individuals who are professional/formal caregivers for the PwD
* Individuals who are cognitively unable to provide informed consent for themselves

Primary outcomes:
measure: Usability scores of first VR intervention used
timeFrame: Day 14 of participation
measure: Usability scores of second VR intervention used
timeFrame: Day 28 of participation
measure: Appropriateness of the study procedures for feasible use of VR-therapy in the home using first intervention
timeFrame: Day 14 of participation
measure: Appropriateness of the study procedures for feasible use of VR-therapy in the home using second intervention
timeFrame: Day 28 of participation
Secondary outcomes:
measure: Change from baseline perceived relationship quality within the participant dyad scores
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline apathy scores in participants with dementia
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline depression scores in participants with dementia
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline depression scores in participants with dementia
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline behavioural disturbance scores in participants with dementia
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline quality of life (QoL) scores for participants with dementia as assessed by the BASQID.
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline quality of life (QoL) scores for participants with dementia and caregiver-participants as assessed by the QoL-AD
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline wellbeing scores for participants with dementia and caregiver-participants as assessed by the WHO (Five) Well-Being Index
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline quality of life (QoL) scores for caregiver-participants as assessed by the Caregiver Self-Assessment Questionnaire
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline quality of life (QoL) scores for caregiver-participants as assessed by the CarerQoL-7D and CarerQoL-VAS
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline feelings of caregiver reward for caregiver-participants
timeFrame: Days 1, 14, and 28 of participation
measure: Change from baseline feelings of caregiver burden for caregiver-participants
timeFrame: Days 1, 14, and 28 of participation
Other outcomes:
Locations:
city: Oakville
country: Canada
facility: Acclaim Health
state: Ontario
city: Toronto
country: Canada
facility: Circle of Care
state: Ontario
Study officials:
References:
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