Virtual reality support for caregivers of people with dementia
A Novel Virtual Reality Intervention for Caregivers of People With Dementia.
This study tests if adding virtual reality experiences to online support programs can help caregivers of people with Alzheimer's feel less stressed and more connected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 1 site (Brescia) |
| Trial ID | NCT05780476 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether a virtual reality experience can enhance the effects of psychoeducational programs for informal caregivers of individuals with mild-to-moderate Alzheimer's disease. Participants will be randomly assigned to either a control group receiving online psychoeducation or an experimental group that combines psychoeducation with virtual reality. The study aims to measure changes in psychological distress and neural activity related to stress and empathic care. By integrating innovative technology with traditional support methods, the trial seeks to improve caregiver well-being.
Who should consider this trial
Good fit: Ideal candidates are unpaid informal caregivers who provide care for a person with mild Alzheimer's disease for at least four hours a day.
Not a fit: Patients who are formal caregivers or those caring for individuals with moderate-to-severe Alzheimer's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce caregiver burden and improve mental health outcomes for those caring for individuals with dementia.
How similar studies have performed: While the use of virtual reality in caregiver support is a novel approach, similar psychoeducational interventions have shown promise in improving caregiver outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brescia
- IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia, Italy (Recruiting)
Study contacts
- Principal investigator: Cristina Festari, PhD — IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
- Study coordinator: Cristina Festari, PhD
- Email: cfestari@fatebenefratelli.eu
- Phone: +39 030 3501335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.