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

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Enrolling

Conditions: Caregiver Burden

Treatments: Behavioral: Psychoeducation + virtual reality; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT05780476

AACSF-22-924470

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control group

Active Comparator group

Description:

Psychoeducational program.

Treatment:

Behavioral: Psychoeducation

Experimental group

Experimental group

Description:

Psychoeducational program combined with virtual reality.

Treatment:

Behavioral: Psychoeducation + virtual reality