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

A Novel Virtual Reality Intervention for Caregivers of People With Dementia.

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.

Study Overview

• Status: Recruiting
• Conditions: Caregiver Burden
• Intervention / Treatment: Behavioral: Psychoeducation; Behavioral: Psychoeducation + virtual reality

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Festari, PhD; Phone Number: +39 030 3501335; Email: cfestari@fatebenefratelli.eu
• Study Contact Backup: Name: Claudio Singh Solorzano, PhD; Email: csolorzano@fatebenefratelli.eu

Study Locations

• Italy
  • Brescia, Italy, 25125
    • Recruiting
    • IRCCS Centro San Giovanni di Dio Fatebenefratelli
    • Contact: Cristina Festari, PhD; Phone Number: +39 030 3501335; Email: cfestari@fatebenefratelli.eu
    • Principal Investigator: Cristina Festari, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Psychoeducational program.	Behavioral: Psychoeducation; 6 sessions of 2 hours over 6 weeks
Experimental: Experimental group; Psychoeducational program combined with virtual reality.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in distress of care after intervention	Zarit Burden interview - ZBI	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Change in anxiety	State Trait Anxiety Inventory - STAI-Y	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in empathy	Interpersonal Reactivity Index - IRI	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Change in sense of competence	Short sense of competence questionnaire - SSCQ	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Modulation of neural activity in brain systems regulating empathy	Task fMRI	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence of medium-term effects - distress of care	Zarit Burden interview - ZBI	2 months post-intervention.
Persistence of medium-term effects - anxiety	State Trait Anxiety Inventory - STAI-Y	2 months post-intervention.
Persistence of medium-term effects - empathy	Interpersonal Reactivity Index - IRI	2 months post-intervention.
Persistence of medium-term effects - sense of competence	Short sense of competence questionnaire - SSCQ	2 months post-intervention.

Collaborators and Investigators

• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Collaborators: Alzheimer's Association; University of Bergamo
• Investigators: Principal Investigator: Cristina Festari, PhD, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

Publications and helpful links

General Publications

• 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.

Helpful Links

• Virtual reality experience

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Virtual reality; Informal caregiver; Psychoeducation intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Stress, Psychological; Dementia; Caregiver Burden
• Other Study ID Numbers: AACSF-22-924470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No