Medication Errors and Other Product Use Errors and IssuesNCT05885347
Innovative Teaching Solutions to Improve the Outcomes of Home Caregivers
A study testing 360 videos, VR and AR in people with Medication Errors and Other Product Use Errors and Issues, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
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. 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
- What is being tested?
- 360 videos, VR and AR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 7 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
- Caregivers currently
Who cannot join
- Be familiar with disruptive technologies or suffer from vertigo
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- 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).
- To determine the effectiveness and cost-effectiveness of VR/AR training in caregiving by caregivers.
- 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.
- 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.
- 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
- 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
- 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.
- Being tested
- 360 videos, VR, AR, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360 videosOther
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.
VROther
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.
AROther
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.
Control groupOther
Caregivers will follow the routine and then will be recorded performing their labour as a caregiver after 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | This caregivers group will not receive any intervention different to the routinely practice. Receives: Other: Control group |
| Video Intervention | Experimental | Caregivers will be taught by a video intervention about how to develop their home tasks during an hour. Receives: Other: 360 videos |
| Virtual reality | Experimental | Caregivers will be taught by a VR intervention during 20minutes about how to develop their home tasks. Receives: Other: VR |
| Augmented reality | Experimental | Caregivers will be taught by a AR intervention during 20minutes about how to develop their home tasks. Receives: Other: AR |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in errors by caregivers at home
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.
Measured: 6 months
Secondary outcomes (1)
Chronic Patient Experience Evaluation Instrument-IEXPAC
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.
Measured: 6 month
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 start1 Feb 2023
- Primary completion28 Feb 2023
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 227 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
- NCT05885347
- Sponsor's protocol ID
- PI00868
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Teaching Solutions to Improve the Outcomes of Home Caregivers
- ClinicalTrials.gov ID
- NCT05885347
- Acronym / sponsor ID
- PI00868
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 7 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.
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.
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
- 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).
- To determine the effectiveness and cost-effectiveness of VR/AR training in caregiving by caregivers.
- 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.
- 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.
- 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
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Control groupThis caregivers group will not receive any intervention different to the routinely practice. |
| Video Intervention | Experimental | Other: 360 videosCaregivers will be taught by a video intervention about how to develop their home tasks during an hour. |
| Virtual reality | Experimental | Other: VRCaregivers will be taught by a VR intervention during 20minutes about how to develop their home tasks. |
| Augmented reality | Experimental | Other: ARCaregivers will be taught by a AR intervention during 20minutes about how to develop their home tasks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers currently
Key exclusion criteria (1 listed)
- Be familiar with disruptive technologies or suffer from vertigo
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 |
|---|---|---|
| 360 videosCaregivers 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. | Other | Video Intervention |
| VRCaregivers 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. | Other | Virtual reality |
| ARCaregivers 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. | Other | Augmented reality |
| Control groupCaregivers will follow the routine and then will be recorded performing their labour as a caregiver after 6 months. | Other | Control group |
Primary outcome
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.
1 secondary outcome
Chronic Patient Experience Evaluation Instrument-IEXPAC
Time frame: 6 month
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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 360 videos, VR and AR in people with Medication Errors and Other Product Use Errors and Issues, 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 1 inclusion and 1 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 4 May 2026. 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 errors by caregivers at home (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.