Safe Use of Medication at Home by Caregivers. Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change from Baseline Health Literacy after the intervention (6 months later).
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Psychoeducational intervention for safe medication use at home + Medication dosing device (Behavioral)
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.
干预措施: Medication dosing device (Device)
结局指标
主要结局
Change from Baseline Health Literacy after the intervention (6 months later).
时间窗: Pre- and post-intervention measurement (6 months time lapse).
Health Literacy validated questionnaire.
Change from Baseline Therapeutic Adherence after the intervention (12 months later).
时间窗: 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).
时间窗: 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).
时间窗: Pre- and post-intervention measurement (12 months time lapse).
Adaptation of the Family Caregiver Activation in Transitions (FCAT) Tool (Coleman et al., 2015).
Change from Baseline Frequency of Medication Errors after the intervention (6 months later).
时间窗: 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 at the time of intervention completion.
时间窗: 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.
时间窗: Post-intervention measure (after 3 months).
Ad hoc survey
Perceived usefulness of the information provided after 6 months from the end of the intervention.
时间窗: Post-intervention measure (after 6 months).
Ad hoc survey
Perceived usefulness of the information provided after 12 months from the end of the intervention.
时间窗: Post-intervention measure (after12 months).
Ad hoc survey
Family Caregivers' Experience at the time of intervention completion.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: Post-intervention measure (after 6 months).
The Measure of the Family Caregivers' Experience (Guilabert et al., 2018).
次要结局
未报告次要终点
研究者
José Joaquín Mira
Professor
Universidad Miguel Hernandez de Elche