Back to resultsA Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare) (VirtualCare)
Primary Purpose
Caregiver Burden
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Psychoeducation
Psychoeducation + virtual reality
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burden focused on measuring Informal caregiver, Virtual reality, Psychoeducation intervention
Eligibility 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.
Sites / Locations
- IRCCS Centro San Giovanni di Dio FatebenefratelliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Psychoeducational program.
Psychoeducational program combined with virtual reality.
Outcomes
Primary Outcome Measures
Change in distress of care after intervention
Zarit Burden interview - ZBI
Change in anxiety
State Trait Anxiety Inventory - STAI-Y
Secondary Outcome Measures
Change in empathy
Interpersonal Reactivity Index - IRI
Change in sense of competence
Short sense of competence questionnaire - SSCQ
Modulation of neural activity in brain systems regulating empathy
Task fMRI
Full Information
NCT ID
NCT05780476
First Posted
February 28, 2023
Last Updated
March 9, 2023
Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborators
Alzheimer's Association, University of Bergamo
1. Study Identification
Unique Protocol Identification Number
NCT05780476
Brief Title
A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)
Acronym
VirtualCare
Official Title
A Novel Virtual Reality Intervention for Caregivers of People With Dementia.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborators
Alzheimer's Association, University of Bergamo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden
Keywords
Informal caregiver, Virtual reality, Psychoeducation intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm randomized controlled design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Psychoeducational program.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Psychoeducational program combined with virtual reality.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
6 sessions of 2 hours over 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation + virtual reality
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in distress of care after intervention
Description
Zarit Burden interview - ZBI
Time Frame
Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Title
Change in anxiety
Description
State Trait Anxiety Inventory - STAI-Y
Time Frame
Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Secondary Outcome Measure Information:
Title
Change in empathy
Description
Interpersonal Reactivity Index - IRI
Time Frame
Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Title
Change in sense of competence
Description
Short sense of competence questionnaire - SSCQ
Time Frame
Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Title
Modulation of neural activity in brain systems regulating empathy
Description
Task fMRI
Time Frame
Baseline (pre-intervention); Post-intervention (up to a week post-intervention).
Other Pre-specified Outcome Measures:
Title
Persistence of medium-term effects - distress of care
Description
Zarit Burden interview - ZBI
Time Frame
2 months post-intervention.
Title
Persistence of medium-term effects - anxiety
Description
State Trait Anxiety Inventory - STAI-Y
Time Frame
2 months post-intervention.
Title
Persistence of medium-term effects - empathy
Description
Interpersonal Reactivity Index - IRI
Time Frame
2 months post-intervention.
Title
Persistence of medium-term effects - sense of competence
Description
Short sense of competence questionnaire - SSCQ
Time Frame
2 months post-intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Festari, PhD
Phone
+39 030 3501335
Email
cfestari@fatebenefratelli.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio Singh Solorzano, PhD
Email
csolorzano@fatebenefratelli.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Festari, PhD
Organizational Affiliation
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Centro San Giovanni di Dio Fatebenefratelli
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Festari, PhD
Phone
+39 030 3501335
Email
cfestari@fatebenefratelli.eu
First Name & Middle Initial & Last Name & Degree
Cristina Festari, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32695039
Citation
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.
Results Reference
background
Links:
URL
https://www.vivede.it/
Description
Virtual reality experience
Learn more about this trial
A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)
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