CompletedNot Applicable

A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)

Italy127 participantsStarted 2022-10-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in distress of care after intervention

Timeframe: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

Change in anxiety

Timeframe: Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

Trial details

NCT IDNCT05780476

SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-27

View on ClinicalTrials.gov More Caregiver Burden trials