- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05885334
Caregivers Training Using Artificial Intelligence and Virtual Reality (RealityCare)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alicante
-
San Juan De Alicante, Alicante, Spain, 03110
- Recruiting
- Fundación Fisabio
-
Contact:
- José Joaquín Mira Solves, PhD
- Phone Number: 606433599
- Email: jose.mira@umh.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study participants are qualified or unqualified caregivers who oversee patients in one of two groups: 1) multi-pathological, polymedicated, dependent, and 2) devices and catheters (oncological, ostomy, etc.). To facilitate recruitment, each centre will be provided with templates adjusted to the participants and arms to which they are committed. The inclusion criteria for each group are detailed below.
Inclusion criteria for carers of multi-pathological, polymedicated and dependent patients
- Qualified or unqualified carers caring for multi-pathological patients (coexistence of two or more chronic conditions lasting one year or more, requiring continuous medical assistance or limiting daily activities), polymedicated (simultaneous daily treatment of 5 or more drugs) and Barthel equal or lower than 55.
- Carers who are in charge of this person for at least 6 months of the year.
- Residence in C. Valenciana, Andalusia, R. de Murcia, C. Madrid and Catalonia (in the home of the patient or relative).
Inclusion criteria for caregivers of patients with devices and catheters
- Qualified or unqualified caregivers in charge of patients with a fixed catheter who require care from another person.
- Carers who are in charge of that person for at least 6 months of the year.
- Residence in C. Valenciana, Andalucía, R. de Murcia, C. Madrid and Cataluña (in the patient's or relative's home).
Exclusion criteria
The exclusion criteria are common to both groups of carers:
- Caregivers of patients who had filed a patrimonial claim in the last 5 years.
- Carers of part-time residents in nursing homes.
- Carers with a health profession.
- Carers of dependent elderly people who do not meet the inclusion criteria.
- Carers with experience in using VR or AR for a similar purpose.
- Carers over 90 years of age.
- Carers with more than two dependents.
- Carers with problems of vertigo, tinnitus, motion sickness, epilepsy, seizures or similar symptoms, severe cardiac conditions or wearing a cardiac pacemaker or hearing aid.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Naturalistic Intervention
Natural intervention (actual provision of information and answering of questions).
This arm will evaluate the natural learning during the action.
|
Caregivers will not receive any educational solution different than what is done by routine in centers.
After six months, performance in caregivers tasks will be video recorded.
|
Experimental: Virtual Reality
Virtual Reality intervention specifically designed for this study.
Using VR to learn procedures will encourage caregivers to learn in a fully immersive and participatory environment where they will have to interact with the virtual content, enhancing their learning experience.
|
Caregivers will receive a educational solution of virtual reality videos with care situations simulations for 1h.
After six months, performance in caregivers tasks will be video recorded.
|
Experimental: Augmented Reality
Augmented Reality Intervention specifically designed for this study.
This intervention will increase participants' skills through active learning as they interact with real-world care situations while receiving simultaneous support from AR devices.
|
Caregivers will receive a educational solution of augmented reality videos with care situations simulations for 1h.
After six months, performance in caregivers tasks will be video recorded.
|
Active Comparator: Videos with 360 degrees
Intervention using immersion 360 degrees specifically designed for this study.
Participants enrolled in this arm, by completing it, is assumed that will experience a form of learning more participatory and immersive than conventional videos, as they can interact with the content by changing the camera angle.
|
Caregivers will receive a educational solution of 360 degrees videos with care situations simulations for 1h.
After six months, performance in caregivers tasks will be video recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of caring errors and medication errors
Time Frame: 6 months
|
The evaluation of the effectiveness of each of the arms will be measured, among other ways, by recording two attempts to execute the care situation to be trained in the intervention.
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6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TED2021-130383B-I00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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