NCT05885334

Brief 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; 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

March 31, 2023

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (3)

Naturalistic Intervention

PLACEBO COMPARATOR

Natural intervention (actual provision of information and answering of questions). This arm will evaluate the natural learning during the action.

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.

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.

Other: Augmented Reality

Interventions

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.

Naturalistic Intervention

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.

Virtual Reality

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.

Augmented Reality

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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).

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Fisabio

Sant Joan d'Alacant, Alicante, 03110, Spain

Location

Related Publications (2)

  • Ballester 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. 2025 Dec 24;41(2):101175. doi: 10.1016/j.jhqr.2025.101175. Online ahead of print.

  • Mira 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 31, 2023

First Posted

June 1, 2023

Study Start

January 15, 2024

Primary Completion

May 31, 2025

Study Completion

July 9, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations