NCT05885347

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

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
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

27 days

First QC Date

March 31, 2023

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Chronic Patient Experience Evaluation Instrument-IEXPAC

    6 month

Study Arms (4)

Control group

PLACEBO COMPARATOR

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

Other: Control group

Video Intervention

EXPERIMENTAL

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

Other: 360 videos

Virtual reality

EXPERIMENTAL

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

Other: VR

Augmented reality

EXPERIMENTAL

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

Other: AR

Interventions

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.

Video Intervention
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.

Virtual reality
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.

Augmented reality

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

Control group

Eligibility Criteria

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

You may qualify if:

  • Caregivers currently

You may not qualify if:

  • Be familiar with disruptive technologies or suffer from vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Fisabio

Sant Joan d'Alacant, Alicante, 03310, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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

February 1, 2023

Primary Completion

February 28, 2023

Study Completion

July 7, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations