Medication Errors and Other Product Use Errors and IssuesRealityCareNCT05885334
Caregivers Training Using Artificial Intelligence and Virtual Reality
A study testing Virtual Reality and Augmented Reality in people with Medication Errors and Other Product Use Errors and Issues and Caring, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
What the investigators propose. The use of disruptive digital technologies for their potential to improve caregivers training, ensure the adequacy of care and achieve a greater quality of life for recipients; increase the efficiency of interventions to support caregivers, quickly reaching a greater number of people… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Errors and Other Product Use Errors and Issues, Caring
- What is being tested?
- Virtual Reality and Augmented Reality
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
What the investigators propose. The use of disruptive digital technologies for their potential to improve caregivers training, ensure the adequacy of care and achieve a greater quality of life for recipients; increase the efficiency of interventions to support caregivers, quickly reaching a greater number of people; democratize access to adequate care; dignify the lives of people working in this sector, mostly women; develop a new sector of the economy by promoting the modernization and technification of the sector. The project seeks to place people at the center of interventions while respecting their digital rights. The investigators identify as disruptive technologies those based on recent innovations (such as virtual and augmented reality, artificial intelligence AI) with a high capacity to evolve rapidly, adapting to very different needs and sectors, and a high capacity to generate new business models. These emerging technologies open up new opportunities to improve the well-being of dependent people, provide new skills (including soft ones) to caregivers and would be also useful against gender stereotypes in the caregiving sector.
Read the detailed description
Feasibility study of VR/AR/AI applications to the context of caregiver training in three phases including mixed methodologies: (1) qualitative (to collect key information to elaborate immersive environments for VR/AR-based interventions), (2) experimental (to test the effectiveness of the intervention targeting caregivers (informal and formal) to provide safe home care, including cost-effectiveness analysis, (3) prototype development to capture and analyze the performance of home care to promote improvements in training programs through VR/AR. General objective. The primary aim is to investigate whether the provision of care in the home of persons suffering multiple pathologies and polypharmacy by trained formal/informal caregivers using VR/AR is more efficient than traditional training. Secondary aims are to provide competencies (knowledge, skills, and attitudes) that contribute to reducing care and medication errors made by caregivers, contributing to recipients staying at home for as long as possible; and to determine to what extent AI allows us to continuously update the VR training material. This Project is in line with the WHO SDG3 "Ensure healthy lives and promote well-being for all at all ages". It also responds to the WHO challenge of Medication Without Harm. At national level, this study reinforces those policies aim to strengthen the new care economy and reduce the gender equality gap (Component 22, June 16, 2021).
- Being tested
- Control, Virtual Reality, Augmented Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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.
Virtual RealityOther
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.
Augmented RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Naturalistic Intervention | Placebo comparator | Natural intervention (actual provision of information and answering of questions). This arm will evaluate the natural learning during the action. Receives: Other: Control |
| Virtual Reality | Experimental | 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. Receives: Other: Virtual Reality |
| Augmented Reality | Experimental | 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. Receives: Other: Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of caring errors and medication errors
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start15 Jan 2024
- Primary completion31 May 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medication Errors and Other Product Use Errors and IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Joaquín Mira Solves, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885334
- Sponsor's protocol ID
- TED2021-130383B-I00
- Acronym
- RealityCare
- Status last verified
- Sep 2025
- First submitted
- 31 Mar 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gil-Hernandez E, Carrillo I, Perez-Esteve C, Arroyo A, Guilabert M, Ballester P, Mira JJ. Enhancing home care safety: a randomized controlled trial of VR-based training for informal caregivers. Int J Med Inform. 2026 Jul 15;215:106444. doi: 10.1016/j.ijmedinf.2026.106444. Epub 2026 Apr 21.
PubMed 42034932Ballester P, Gil-Hernandez E, Perez-Esteve C, Guilabert M, Carrillo I, Arroyo A, Cobos A, Mira JJ. Medication incidents and informal caregiver burden: A cross-sectional study. J Healthc Qual Res. 2026 Mar-Apr;41(2):101175. doi: 10.1016/j.jhqr.2025.101175. Epub 2025 Dec 24.
PubMed 41447744Mira JJ, Ballester P, Gil-Hernandez E, Sambrano Valeriano L, Alvarez Gomez E, Olier Garate C, Marquez Ruiz A, Acedo Torrecilla M, Arroyo Rodriguez A, Hidalgo Galache E, Navas Gutierrez P, Perez-Jover V, Lorenzo Martinez S, Carrillo Murcia I, Fernandez Peris C, Sanchez-Garcia A, Vicente Ripoll MA, Cobos Vargas A, Perez-Perez P, Guilabert Mora M. Safe Care and Medication Intake Provided by Caregivers at Home: Reality Care Study Protocol. Healthcare (Basel). 2023 Aug 3;11(15):2190. doi: 10.3390/healthcare11152190.
PubMed 37570430
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregivers Training Using Artificial Intelligence and Virtual Reality
- ClinicalTrials.gov ID
- NCT05885334
- Acronym / sponsor ID
- RealityCare / TED2021-130383B-I00
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What the investigators propose. The use of disruptive digital technologies for their potential to improve caregivers training, ensure the adequacy of care and achieve a greater quality of life for recipients; increase the efficiency of interventions to support caregivers, quickly reaching a greater number of people; democratize access to adequate care; dignify the lives of people working in this sector, mostly women; develop a new sector of the economy by promoting the modernization and technification of the sector. The project seeks to place people at the center of interventions while respecting their digital rights. The investigators identify as disruptive technologies those based on recent innovations (such as virtual and augmented reality, artificial intelligence AI) with a high capacity to evolve rapidly, adapting to very different needs and sectors, and a high capacity to generate new business models. These emerging technologies open up new opportunities to improve the well-being of dependent people, provide new skills (including soft ones) to caregivers and would be also useful against gender stereotypes in the caregiving sector.
Detailed description
Feasibility study of VR/AR/AI applications to the context of caregiver training in three phases including mixed methodologies: (1) qualitative (to collect key information to elaborate immersive environments for VR/AR-based interventions), (2) experimental (to test the effectiveness of the intervention targeting caregivers (informal and formal) to provide safe home care, including cost-effectiveness analysis, (3) prototype development to capture and analyze the performance of home care to promote improvements in training programs through VR/AR. General objective. The primary aim is to investigate whether the provision of care in the home of persons suffering multiple pathologies and polypharmacy by trained formal/informal caregivers using VR/AR is more efficient than traditional training. Secondary aims are to provide competencies (knowledge, skills, and attitudes) that contribute to reducing care and medication errors made by caregivers, contributing to recipients staying at home for as long as possible; and to determine to what extent AI allows us to continuously update the VR training material. This Project is in line with the WHO SDG3 "Ensure healthy lives and promote well-being for all at all ages". It also responds to the WHO challenge of Medication Without Harm. At national level, this study reinforces those policies aim to strengthen the new care economy and reduce the gender equality gap (Component 22, June 16, 2021).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naturalistic Intervention | Placebo comparator | Other: ControlNatural intervention (actual provision of information and answering of questions). This arm will evaluate the natural learning during the action. |
| Virtual Reality | Experimental | Other: Virtual RealityVirtual 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. |
| Augmented Reality | Experimental | Other: Augmented RealityAugmented 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlCaregivers 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. | Other | Naturalistic Intervention |
| Virtual RealityCaregivers 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. | Other | Virtual Reality |
| Augmented RealityCaregivers 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. | Other | Augmented Reality |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 42034932Gil-Hernandez E, Carrillo I, Perez-Esteve C, Arroyo A, Guilabert M, Ballester P, Mira JJ. Enhancing home care safety: a randomized controlled trial of VR-based training for informal caregivers. Int J Med Inform. 2026 Jul 15;215:106444. doi: 10.1016/j.ijmedinf.2026.106444. Epub 2026 Apr 21.
- Derived from this study: PubMed 41447744Ballester P, Gil-Hernandez E, Perez-Esteve C, Guilabert M, Carrillo I, Arroyo A, Cobos A, Mira JJ. Medication incidents and informal caregiver burden: A cross-sectional study. J Healthc Qual Res. 2026 Mar-Apr;41(2):101175. doi: 10.1016/j.jhqr.2025.101175. Epub 2025 Dec 24.
- Derived from this study: PubMed 37570430Mira JJ, Ballester P, Gil-Hernandez E, Sambrano Valeriano L, Alvarez Gomez E, Olier Garate C, Marquez Ruiz A, Acedo Torrecilla M, Arroyo Rodriguez A, Hidalgo Galache E, Navas Gutierrez P, Perez-Jover V, Lorenzo Martinez S, Carrillo Murcia I, Fernandez Peris C, Sanchez-Garcia A, Vicente Ripoll MA, Cobos Vargas A, Perez-Perez P, Guilabert Mora M. Safe Care and Medication Intake Provided by Caregivers at Home: Reality Care Study Protocol. Healthcare (Basel). 2023 Aug 3;11(15):2190. doi: 10.3390/healthcare11152190.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Augmented Reality in people with Medication Errors and Other Product Use Errors and Issues and Caring, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of caring errors and medication errors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885334, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.