Miguel Hernández University
Elche, Alicante, 03202, Spain
Completed
NCT Number: NCT05247801
Safe Use of Medication at Home by Caregivers. Experimental Study
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).
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Psychoeducational intervention for safe medication use at home + Medication dosing device
BehavioralThe 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.
Medication dosing device
DeviceUse of medication dosing device.
Primary outcomes
-
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).
-
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.
-
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.
-
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.
-
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).
-
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
-
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
-
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
-
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
-
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).
-
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).
-
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).
-
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).
Sponsors and collaborators
Lead sponsor
Universidad Miguel Hernandez de Elche
Other
Collaborators
- Fondo de Investigación en Salud (FIS)
- Fundación Pública Andaluza Progreso y Salud
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Hospital General de Elda
- Hospital Universitari Sant Joan d'Alacant
- Hospital Universitario San Cecilio
- Servicio Aragones De Salud
- Servicio Navarro de Salud - Osasunbidea
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Feb 21, 2022
- Registry last updated
- Jun 26, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.