Clinical trial NCT05885334: Caregivers Training Using Artificial Intelligence and Virtual Reality
Official title: Caregivers Training Using Artificial Intelligence and Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Errors and Other Product Use Errors and Issues
Caring
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of caring errors and medication errors
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan De Alicante
country: Spain
facility: Fundación Fisabio
state: Alicante
Study officials:
References: