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Safe Use of Medication at Home by Caregivers. Experimental Study

Safe Use of Medication at Home by Caregivers. Experimental Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05247801
Enrollment
142
Registered
2022-02-21
Start date
2022-04-11
Completion date
2024-12-12
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers of Multi-pathological and Polypharmacy Adults

Keywords

Medication Errors, Patient Safety, Psychoeducational Intervention, Risk Management, Health Literacy

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.

Interventions

BEHAVIORALPsychoeducational 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.

DEVICEMedication dosing device

Use of medication dosing device.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Participants. Caregivers of multi-pathological and polypharmacy patients (Barthel equal to or lower than 55). Recruitment will be carried out by simple randomization based on the diaries of patients seen in the last 18 months in the collaborating centers. Intervention. Psychoeducational intervention based on virtual reality aimed at increasing self-efficacy and health literacy in medication use. Procedure. By simple randomization, participants will be assigned to one of the two groups (control or experimental) after giving their informed consent. They will not know to which group they belong. Treatments. The subjects in the control group will use a dosing device and will receive information on how to use it to avoid medication errors. The experimental group will receive the psychoeducational intervention and the same medication device. The experimental group will receive the psychoeducational intervention. Intervention period: 15 days. Follow-up: 6 months.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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.
Perceived usefulness of the information provided after 6 months from the end of the intervention.Post-intervention measure (after 6 months).Ad hoc survey
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
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).
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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026