Innovative Teaching Solutions to Improve the Outcomes of Home Caregivers

NCT ID: NCT05885347

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-12-31

Brief 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. 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

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.

Conditions

Medication Errors and Other Product Use Errors and Issues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

This caregivers group will not receive any intervention different to the routinely practice.

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: OTHER

Caregivers will follow the routine and then will be recorded performing their labour as a caregiver after 6 months.

Video Intervention

Caregivers will be taught by a video intervention about how to develop their home tasks during an hour.

Group Type: EXPERIMENTAL

360 videos

Intervention Type: OTHER

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.

Virtual reality

Caregivers will be taught by a VR intervention during 20minutes about how to develop their home tasks.

Group Type: EXPERIMENTAL

VR

Intervention Type: OTHER

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.

Augmented reality

Caregivers will be taught by a AR intervention during 20minutes about how to develop their home tasks.

Group Type: EXPERIMENTAL

AR

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Control group

Caregivers will follow the routine and then will be recorded performing their labour as a caregiver after 6 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Caregivers currently

Exclusion Criteria

• Be familiar with disruptive technologies or suffer from vertigo

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role: lead

Responsible Party

José Joaquín Mira Solves

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fundación Fisabio

Sant Joan d'Alacant, Alicante, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PI00868

Identifier Type: -

Identifier Source: org_study_id