Innovative Teaching Solutions to Improve the Outcomes of Home Caregivers

April 28, 2026 updated by: José Joaquín Mira Solves, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Background. Population ageing is leading to an increase in the number of multi-pathological and polymedicated patients. These patients are at increased risk of suffering adverse events due to medication errors (ME), especially if Barthel≤55. The management of their medication places an added burden of stress on those who assume responsibility for their care. This task, due to the existing gender gap, falls more often on women.

Objective. To promote the safe use of medication in the home by those who assume the role of caregivers of these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

General objective. The main objective is to investigate whether the provision of care at home by caregivers of of people with multi-pathology and polypharmacy by formal/informal caregivers trained in VR/AR is more efficient formal/informal caregivers trained through VR/AR is more efficient than traditional training.

Secondary objectives are to provide competencies (knowledge, skills and attitudes) that contribute to reducing attitudes) that contribute to reducing caregiver care and medication errors by helping caregivers caregivers, helping beneficiaries to stay at home for as long as possible; and to determine the extent to which and to determine the extent to which AI allows us to continuously update VR training material.

VR training material. This project is in line with the WHO SDG 3. "Ensure healthy lives and promote well-being for all at all ages". It also responds to the WHO Medicines Without Harm challenge. At the national level, this study study reinforces those policies that aim to strengthen the new care economy and reduce the gender equality reduce the gender equality gap (Component 22, 16 June 2021). Specific objectives

  1. To create innovative materials to increase the effectiveness of training for formal and informal caregivers through informal and formal caregivers through VR/AR (fully immersive 3D videos).
  2. To determine the effectiveness and cost-effectiveness of VR/AR training in caregiving by caregivers.

2. To determine the effectiveness and cost-effectiveness of VR/AR training in the provision of care by formal and informal caregivers and compare it with the outcomes of training using traditional procedures.

outcomes of training using traditional procedures. 3. To analyse the ability of VR/AR to reduce errors in the provision of home-based care and medication by formal and informal caregivers and to compare it with the results of training using traditional procedures.

3. To analyse the ability of RL/RH to reduce errors in the provision of care and medication in the home by formal and informal caregivers.

4. To determine the usefulness of VR/RA in increasing caregivers' self-confidence, considering gender-related factors. 5. Determine the feasibility of combining the analysis of data captured during home care using AI (Deep home care using AI (Deep Learning) and the latest technological developments in VR/AR for smartphones in VR/AR for smartphones - virtual mapping (Arcore 1.24) and AR interaction (LifeAR) - to generate fully immersive generate fully immersive environments for caregiver training. METHODOLOGY Feasibility study of VR/AR/AR/IA applications in the context of caregiver training in three phases

  1. qualitative (to collect key information for the development of immersive environments for the key information to develop immersive environments for VR/AR-based interventions), (2) qualitative (to collect key VR/AR-based interventions), (2) experimental (to test the effectiveness of the intervention targeting caregivers (informal and formal), (3) qualitative (to test the effectiveness of the caregivers (informal and formal) to provide safe home-based care, including cost-effectiveness analysis, (3) experimental (to test effectiveness of cost-effectiveness analysis, (3) prototype development to capture and analyse performance of home-based care to
  2. development of prototypes to capture and analyse home-based care performance to promote improvements in training programmes through VR/AR.

training programmes through VR/AR.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
227

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Sant Joan d'Alacant, Alicante, Spain, 03310
        • Fundación Fisabio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Caregivers currently

Exclusion Criteria:

  • Be familiar with disruptive technologies or suffer from vertigo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group
This caregivers group will not receive any intervention different to the routinely practice.
Other: Control group
Caregivers will follow the routine and then will be recorded performing their labour as a caregiver after 6 months.
Experimental: Video Intervention
Caregivers will be taught by a video intervention about how to develop their home tasks during an hour.
Other: 360 videos
Caregivers will receive 2h session of 360 videos about caring and medication errors. Then Caregivers will be recorded performed the task worked in 360 videos instantly after the education and after 6 months.
Experimental: Virtual reality
Caregivers will be taught by a VR intervention during 20minutes about how to develop their home tasks.
Other: VR
Caregivers will receive 2h session of VR about caring and medication errors. Then Caregivers will be recorded performed the task worked inVR instantly after the education and after 6 months.
Experimental: Augmented reality
Caregivers will be taught by a AR intervention during 20minutes about how to develop their home tasks.
Other: AR
Caregivers will receive 2h session of AR videos about caring and medication errors. Then Caregivers will be recorded performed the task worked in AR videos instantly after the education and after 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in errors by caregivers at home
Time Frame: 6 months
Caregivers will be recorded in the hospital performing their task in a simulation. All errors performed doing that situation will be counted by professionals who will reproduce that videos.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Chronic Patient Experience Evaluation Instrument-IEXPAC
Time Frame: 6 month
Questionnaire regarding the experience of the patient care in a chronic situation, with 16 statements, that should be read in the order in which they appear and choose the option that best reflects the opinion. There are no right or wrong answers, it is own personal experience that matters. All statements refer to the last 6 months.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI00868

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

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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