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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of VR Educational Program on Empathy and Attitudes Toward Dementia in Caregivers

NCT06072274

Dementia Caregiver Burden

COMPLETED NA

A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia

NCT05475002

Dementia Family Caregiver

COMPLETED NA

Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial

NCT04280861

Alzheimer Disease Caregivers Quality of Life

UNKNOWN NA

Evaluation of the Effectiveness of Virtual Reality Headsets With Hypnotic Scenarios for Hygiene Care in Patients With Alzheimer's Disease or Related Disorders With Behavioral Disturbances

NCT07264439

Effectiveness Virtual Reality Hypnotic Scenarios +3 more

RECRUITING NA

Dementia Care Training With Virtual Reality and Support for Home Care Staff

NCT04788992

Dementia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caregiver Burden

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm randomized controlled design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Psychoeducational program.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

6 sessions of 2 hours over 6 weeks

Experimental group

Psychoeducational program combined with virtual reality.

Group Type EXPERIMENTAL

Psychoeducation + virtual reality

Intervention Type BEHAVIORAL

6 sessions of 2 hours over 6 weeks. Virtual reality experience will be carry out in the last 30 minutes of each meeting. Virtual reality consists of 360-degree videos depicting everyday situations and allowing the caregivers to feel the specific symptoms of dementia (e.g., disorientation, agnosia, apraxia and memory loss).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychoeducation

6 sessions of 2 hours over 6 weeks

Intervention Type BEHAVIORAL

Psychoeducation + virtual reality

6 sessions of 2 hours over 6 weeks. Virtual reality experience will be carry out in the last 30 minutes of each meeting. Virtual reality consists of 360-degree videos depicting everyday situations and allowing the caregivers to feel the specific symptoms of dementia (e.g., disorientation, agnosia, apraxia and memory loss).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* Medical history of epilepsy.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes