Safe Use of Medication at Home by Caregivers. Experimental Study

June 20, 2025 updated by: José Joaquín Mira, Universidad Miguel Hernandez de Elche

Experimental study to test the effectiveness of a psychoeducational intervention using virtual reality, aimed at caregivers of multi-pathological and polypharmacy persons to promote safer medication use at home. Experimental design with two groups (experimental and control), pre-post measures, and participants assignment to groups by simple randomization.

Null hypothesis. There will be no differences in the frequency of medication errors at home, the severity of the consequences of medication errors, perceived self-efficacy, and health literacy between caregivers using a dosing device (control group) and caregivers using a dosing device with the reinforcement of a psychoeducational intervention designed ad hoc (experimental group).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background. Population aging 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.

Method. Mixed research study. First: Nominal groups (N=128) and survey (N=1255) to design a psychoeducational intervention aimed at caregivers based on the identification of ME, its causes and consequences, and risk factors that contribute to ME. Second: Single-subject experimental design (two groups, experimental and control, with pre-post measures) to determine the effectiveness of the psycho-educational intervention (n=142).

Setting. Primary care centers and caregivers' associations and training schools in Alicante, Granada, Madrid, Pamplona, Seville, and Zaragoza.

Expected results. Identify critical elements for medication risk management in the home by caregivers. Low-cost psycho-educational intervention for safer use of medication adjusted to the possible different needs of male and female caregivers. The transfer of results will be mainly oriented to reinforce the action carried out by nursing and caregivers' training schools.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Miguel Hernández University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Caregivers of multi-pathological and polypharmacy patients (Barthel equal to or less than 55).
  • Residence in Alicante, Granada, Madrid, Pamplona, Seville, or Zaragoza (in the patient's home or the family member's home).
  • At patient's charge for at least six months during the year.

Exclusion Criteria:

  • Caregivers of patients who are institutionalized a minimum of 3 months per year.
  • Caregivers with experience of more than six months in the use of medication dosing devices.
  • Health education/profession.
  • Filing of a property claim in the last 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (Psychoeducational Intervention)
Seventy one caregivers of multi-pathological and polypharmacy patients will receive psychoeducational intervention based on virtual reality and a dosing device for safer medication use at home. The intervention will be developed in a previous project phase using a mixed methodology (observational study and qualitative techniques). The intervention will be group-based and consist of motivational discussions and a review of audiovisual materials to promote self-efficacy and health literacy on the safe use of medication at home (most frequent errors, preventive strategies, etc.). Study period: 15 days intervention and follow-up 6 months.
Behavioral: Psychoeducational intervention for safe medication use at home + Medication dosing device

The intervention is yet to be defined. Psychoeducational intervention based on virtual reality, demonstrations, and psychoeducational content using virtual reality. Contents:

Most frequent medication errors at home. Approaches to risk management in the home. Correct use of the most common medications in different patient profiles. Strategies to avoid medication errors. Guidance to alleviate the burden of responsibility suffered by women as a result of the gender bias derived from assuming the caregiver role.

Other.
Active Comparator: Control Group (Dosing Device)
The 71 subjects assigned to the control group will use a medication dosing device and will receive information on how to use it for medication errors. Study period: 15 days intervention and follow-up 6 months.
Device: Medication dosing device
Use of medication dosing device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Therapeutic Adherence after the intervention (12 months later).
Time Frame: Pre- and post-intervention measurement (12 months time lapse).
Therapeutic Adherence validated questionnaire.
Pre- and post-intervention measurement (12 months time lapse).
Change from Baseline Locus of Control after the intervention (12 months later).
Time Frame: Pre- and post-intervention measurement (12 months time lapse).
Locus of Control Test - Abridged.
Pre- and post-intervention measurement (12 months time lapse).
Change from Baseline Self-efficacy after the intervention (12 months later).
Time Frame: Pre- and post-intervention measurement (12 months time lapse).
Adaptation of the Family Caregiver Activation in Transitions (FCAT) Tool (Coleman et al., 2015).
Pre- and post-intervention measurement (12 months time lapse).
Perceived usefulness of the information provided at the time of intervention completion.
Time Frame: Post-intervention measure (15 days after the start of the intervention).
Ad hoc survey
Post-intervention measure (15 days after the start of the intervention).
Perceived usefulness of the information provided after 3 months from the end of the intervention.
Time Frame: Post-intervention measure (after 3 months).
Ad hoc survey
Post-intervention measure (after 3 months).
Perceived usefulness of the information provided after 6 months from the end of the intervention.
Time Frame: Post-intervention measure (after 6 months).
Ad hoc survey
Post-intervention measure (after 6 months).
Perceived usefulness of the information provided after 12 months from the end of the intervention.
Time Frame: Post-intervention measure (after12 months).
Ad hoc survey
Post-intervention measure (after12 months).
Family Caregivers' Experience at the time of intervention completion.
Time Frame: Post-intervention measure (15 days after the start of the intervention).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (15 days after the start of the intervention).
Family Caregivers' Experience after 3 months from the end of the intervention.
Time Frame: Post-intervention measure (after 3 months).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (after 3 months).
Family Caregivers' Experience after 6 months from the end of the intervention.
Time Frame: Post-intervention measure (after 6 months).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (after 6 months).
Change from Baseline Frequency of Medication Errors after the intervention (6 months later).
Time Frame: Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).
The number of medication errors, type, and consequences (adverse events and consumption of healthcare resources to mitigate the effect of the error). Self-reported measure. Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).
Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).
Change from Baseline Health Literacy after the intervention (6 months later).
Time Frame: Pre- and post-intervention measurement (6 months time lapse).
Health Literacy validated questionnaire.
Pre- and post-intervention measurement (6 months time lapse).
Family Caregivers' Experience after 12 months from the end of the intervention.
Time Frame: Post-intervention measure (after 6 months).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Post-intervention measure (after 6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

Fundación Pública Andaluza Progreso y Salud
Servicio Aragonés de Salud (SALUD)
Fondo de Investigación en Salud (FIS)
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana
Hospital General de Elda
Servicio Navarro de Salud - Osasunbidea
Hospital Universitari Sant Joan d'Alacant
Hospital Universitario San Cecilio

Investigators

  • Principal Investigator: José Joaquín Mira, Ph.D., Univ. Miguel Hernández; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la CV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Actual)

November 13, 2024

Study Completion (Actual)

December 12, 2024

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI21/00646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The databases, without identification and code registration, will be available at OSF (Center for Open Science) for access by the scientific community. the scientific community.

IPD Sharing Time Frame

Six months after the data collecting.

IPD Sharing Access Criteria

Data repository is available for the scientific community.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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