Clinical trial NCT05780476: A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)
Official title: A Novel Virtual Reality Intervention for Caregivers of People With Dementia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Keywords: Informal caregiver
Virtual reality
Psychoeducation intervention
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: University of Bergamo
First posted: 2023-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled design
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial aims to explore if a virtual reality experience increases the beneficial effect of psychoeducational programs in informal caregivers of people with mild-to-moderate Alzheimer's disease. This study will test changes in psychological distress and neural activity in brain systems that regulate stress and empathic care.

Participants will be randomized into two arms: the control group will participate in an online psychoeducational intervention, while the experimental group will participate in the psychoeducational intervention combined with virtual reality.


Eligibility criteria: Inclusion Criteria:

* Being an unpaid informal caregiver (CG; i.e., family members or friends) living with or caring for a person with Alzheimer's Disease (AD) for at least 4 hours a day for at least six months before enrolment;
* Caring for a person with a diagnosis of AD at prodromal or mild stage (i.e., Mini-Mental State Examination score:18-24) and still living at home.

Exclusion Criteria:

* Receiving daily assistance for more than 10 hours from formal CGs;
* Being formal CGs (i.e., nurse or another paid figure);
* Being informal CGs of i) persons with moderate-to-severe AD, or ii) persons with non-AD diseases;
* Not having or being able to use a device connected to internet (e.g., smartphones or PC).
* Having received psychotherapeutic o psychological support, or having already participated to psychoeducational programs.
* Only a family member for person with dementia is accepted.

Exclusion Criteria for experimental group (Psychoeducation + VR):

* Medical history of epilepsy.

Exclusion Criteria for subsample of caregivers assess with MRI:

* Metal implants, artificial prostheses, pace-makers, prosthetic heart valves;
* Claustrophobia;
* Pregnancy.

Primary outcomes:
measure: Change in distress of care after intervention
timeFrame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
measure: Change in anxiety
timeFrame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Secondary outcomes:
measure: Change in empathy
timeFrame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
measure: Change in sense of competence
timeFrame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
measure: Modulation of neural activity in brain systems regulating empathy
timeFrame: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Other outcomes:
measure: Persistence of medium-term effects - distress of care
timeFrame: 2 months post-intervention.
measure: Persistence of medium-term effects - anxiety
timeFrame: 2 months post-intervention.
measure: Persistence of medium-term effects - empathy
timeFrame: 2 months post-intervention.
measure: Persistence of medium-term effects - sense of competence
timeFrame: 2 months post-intervention.
Locations:
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study officials:
affiliation: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
name: Cristina Festari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morganti F, Palena N, Savoldelli P, Greco A. Take the First-Person Perspective to Become Dementia-Friendly: The Use of 360 degrees Video for Experiencing Everyday-Life Challenges With Cognitive Decline. Front Psychol. 2020 Jun 30;11:1117. doi: 10.3389/fpsyg.2020.01117. eCollection 2020.