Safe Use of Medication at Home by Caregivers. Experimental Study

Not Applicable

Completed

• Conditions: Caregivers of Multi-pathological and Polypharmacy Adults

• Registration Number: NCT05247801
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief Summary

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).

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 Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-21
• Study Start: 2022-04-11
• Primary Completion: 2024-11-13
• Study Completion: 2024-12-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived usefulness of the information provided after 12 months from the end of the intervention.	Post-intervention measure (after12 months).	Ad hoc survey
Family Caregivers' Experience at the time of intervention completion.	Post-intervention measure (15 days after the start of the intervention).	The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Family Caregivers' Experience after 3 months from the end of the intervention.	Post-intervention measure (after 3 months).	The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Family Caregivers' Experience after 6 months from the end of the intervention.	Post-intervention measure (after 6 months).	The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Family Caregivers' Experience after 12 months from the end of the intervention.	Post-intervention measure (after 6 months).	The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Change from Baseline Frequency of Medication Errors after the intervention (6 months later).	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).
Change from Baseline Health Literacy after the intervention (6 months later).	Pre- and post-intervention measurement (6 months time lapse).	Health Literacy validated questionnaire.
Change from Baseline Therapeutic Adherence after the intervention (12 months later).	Pre- and post-intervention measurement (12 months time lapse).	Therapeutic Adherence validated questionnaire.
Change from Baseline Locus of Control after the intervention (12 months later).	Pre- and post-intervention measurement (12 months time lapse).	Locus of Control Test - Abridged.
Change from Baseline Self-efficacy after the intervention (12 months later).	Pre- and post-intervention measurement (12 months time lapse).	Adaptation of the Family Caregiver Activation in Transitions (FCAT) Tool (Coleman et al., 2015).
Perceived usefulness of the information provided at the time of intervention completion.	Post-intervention measure (15 days after the start of the intervention).	Ad hoc survey
Perceived usefulness of the information provided after 3 months from the end of the intervention.	Post-intervention measure (after 3 months).	Ad hoc survey
Perceived usefulness of the information provided after 6 months from the end of the intervention.	Post-intervention measure (after 6 months).	Ad hoc survey

Trial Locations

Locations (1)

Miguel Hernández University; 🇪🇸 Elche, Alicante, Spain