Safe Use of Medication at Home by Caregivers. Experimental Study

Miguel Hernández University of Elche

Status: Completed

Conditions: Caregivers of Multi-pathological and Polypharmacy Adults

Treatments: Device: Medication dosing device; Behavioral: Psychoeducational intervention for safe medication use at home + Medication dosing device

Study type: Interventional

Funder types: Other

Identifiers

NCT05247801

PI21/00646

Details and patient eligibility

About

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).

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups

Experimental Group (Psychoeducational Intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Psychoeducational intervention for safe medication use at home + Medication dosing device

Control Group (Dosing Device)

Active Comparator group

Description:

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.

Treatment:

Device: Medication dosing device