Safe Use of Medication at Home by Caregivers. Experimental Study
NCT ID: NCT05247801
Last Updated: 2025-06-26
Study Results
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Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2022-04-11
2024-12-12
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
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.
Medication dosing device
Use of medication dosing device.
Interventions
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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.
Medication dosing device
Use of medication dosing device.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
Yes
Sponsors
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Servicio Aragonés de Salud (SALUD)
UNKNOWN
Fondo de Investigación en Salud (FIS)
UNKNOWN
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana
UNKNOWN
Hospital General de Elda
OTHER
Servicio Navarro de Salud - Osasunbidea
UNKNOWN
Hospital Universitari Sant Joan d'Alacant
UNKNOWN
Hospital Universitario San Cecilio
UNKNOWN
Fundación Pública Andaluza Progreso y Salud
OTHER
Universidad Miguel Hernandez de Elche
OTHER
Responsible Party
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José Joaquín Mira
Professor
Principal Investigators
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José Joaquín Mira, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Univ. Miguel Hernández; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la CV
Locations
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Miguel Hernández University
Elche, Alicante, Spain
Countries
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References
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Other Identifiers
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PI21/00646
Identifier Type: -
Identifier Source: org_study_id
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