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

Caregiver Burden Clinical Trial

— VirtualCare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780476
• Other study ID #: AACSF-22-924470
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2023
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: Cristina Festari, PhD
• Phone: +39 030 3501335
• Email: cfestari[@]fatebenefratelli.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Dementia

Intervention

Behavioral:
• Psychoeducation
6 sessions of 2 hours over 6 weeks
• 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).

Locations

Country	Name	City	State
Italy	IRCCS Centro San Giovanni di Dio Fatebenefratelli	Brescia

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS Centro San Giovanni di Dio Fatebenefratelli	Alzheimer's Association, University of Bergamo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Persistence of medium-term effects - distress of care	Zarit Burden interview - ZBI	2 months post-intervention.
Other	Persistence of medium-term effects - anxiety	State Trait Anxiety Inventory - STAI-Y	2 months post-intervention.
Other	Persistence of medium-term effects - empathy	Interpersonal Reactivity Index - IRI	2 months post-intervention.
Other	Persistence of medium-term effects - sense of competence	Short sense of competence questionnaire - SSCQ	2 months post-intervention.
Primary	Change in distress of care after intervention	Zarit Burden interview - ZBI	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Primary	Change in anxiety	State Trait Anxiety Inventory - STAI-Y	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Secondary	Change in empathy	Interpersonal Reactivity Index - IRI	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Secondary	Change in sense of competence	Short sense of competence questionnaire - SSCQ	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Secondary	Modulation of neural activity in brain systems regulating empathy	Task fMRI	Baseline (pre-intervention); Post-intervention (up to a week post-intervention).

External Links

•   Virtual reality experience