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).
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
142
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.
Use of medication dosing device.
Miguel Hernández University
Elche, Alicante, Spain
Change from Baseline Frequency of Medication Errors after the intervention (6 months later).
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).
Time frame: Pre-intervention measure (6 months prior). Post-intervention measure (last 6 months).
Change from Baseline Health Literacy after the intervention (6 months later).
Health Literacy validated questionnaire.
Time frame: Pre- and post-intervention measurement (6 months time lapse).
Change from Baseline Therapeutic Adherence after the intervention (12 months later).
Therapeutic Adherence validated questionnaire.
Time frame: Pre- and post-intervention measurement (12 months time lapse).
Change from Baseline Locus of Control after the intervention (12 months later).
Locus of Control Test - Abridged.
Time frame: Pre- and post-intervention measurement (12 months time lapse).
Change from Baseline Self-efficacy after the intervention (12 months later).
Adaptation of the Family Caregiver Activation in Transitions (FCAT) Tool (Coleman et al., 2015).
Time frame: Pre- and post-intervention measurement (12 months time lapse).
Perceived usefulness of the information provided at the time of intervention completion.
Ad hoc survey
Time frame: 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.
Ad hoc survey
Time frame: Post-intervention measure (after 3 months).
Perceived usefulness of the information provided after 6 months from the end of the intervention.
Ad hoc survey
Time frame: Post-intervention measure (after 6 months).
Perceived usefulness of the information provided after 12 months from the end of the intervention.
Ad hoc survey
Time frame: Post-intervention measure (after12 months).
Family Caregivers' Experience at the time of intervention completion.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Time frame: Post-intervention measure (15 days after the start of the intervention).
Family Caregivers' Experience after 3 months from the end of the intervention.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Time frame: Post-intervention measure (after 3 months).
Family Caregivers' Experience after 6 months from the end of the intervention.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Time frame: Post-intervention measure (after 6 months).
Family Caregivers' Experience after 12 months from the end of the intervention.
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
Time frame: Post-intervention measure (after 6 months).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.