Efficacy of an Intervention to Increase Therapeutic Adherence in Patients With Secondary Prevention for Cardiovascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Therapeutic adherence
研究概览
简要总结
The goal of this open label randomized controlled trial is to evaluate the efficacy of an intervention through health education based on the Chronic Care Model's implementation to increase therapeutic adherence in patients with secondary prevention for cardiovascular disease. The main questions it aims to answer are:
- Null hypothesis (H0): In patients in cardiovascular secondary prevention, an intervention based on the application of the Chronic Care Model does not improve therapeutic adherence to the 3 preventive drugs: Angiotensin converting enzyme inhibitors/Angiotensin II receptor blockers, acetylsalicylic acid, and statins.
- Alternative hypothesis (H1): In patients in cardiovascular secondary prevention, an intervention based on the application of the Chronic Care Model improves therapeutic adherence to the 3 preventive drugs: Angiotensin converting enzyme inhibitors/Angiotensin II receptor blockers, acetylsalicylic acid, and statins.
Researchers will compare intervention group (health education, use of mobile phones, personalized dosage system) to the control group (routine follow-up).
详细描述
Cardiovascular diseases are the worldwide's leading cause of mortality. Within the spectrum of these diseases, cerebrovascular disease, coronary heart disease, and peripheral vascular disease are included. Secondary prevention is an effective strategy in patients with previous events, being the most used drugs antihypertensives, statins and salicylic acetyl acid.
Therapeutic adherence in these patients is crucial, as the lack of it, results in increased morbidity and mortality, as well as decreased quality of life and raised healthcare costs. However, less than half of the patients take all three medications during the first year. In addition, the lack of therapeutic adherence is easier to measure in the primary care setting.
Objective: To evaluate the efficacy of an intervention through health education based on the Chronic Care Model's implementation to increase therapeutic adherence in patients with secondary prevention for cardiovascular disease.
Methods: Open label randomized controlled trial, selecting patients presenting the inclusion criteria through consecutive probability sampling. Random assignment will be carried out using a random number table.
Intervention on patients in the experimental group will be conducted through health education following the recommendations of the Chronic Care Model (CCM). The aim is to empower patients to manage their disease through therapeutic education measures and shared decision-making with the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, aged over 18 years old, who, after reading the patient information sheet, provide written informed consent.
- •Patients in secondary prevention receiving daily single-dose angiotensin converting enzyme inhibitors/Angiotensin II receptor blockers, acetylsalicylic acid, and statins for 6 months or more.
- •Diagnosis of any of the following cardiovascular diseases: cerebrovascular disease, ischemic heart disease, or peripheral vascular disease.
- •Patients under follow-up at our primary care center.
- •Patients identified with therapeutic adherence deficiency, defined as Haynes-Sackett test supplemented with Medication Possession Ratio (MPR) < 80% for any of the 3 drugs in the previous 6 months.
排除标准
- •Patients who refuse to participate.
- •Incomplete completion of informed consent.
- •Language barrier.
- •Patients diagnosed with psychiatric, psychological, neurological, and/or social problems that hinder intervention or follow-up.
- •Life expectancy less than one year.
- •Patients whose treatment is managed by a caregiver (professional or family member).
- •Patients with Barthel Index <
- •Institutionalized patients.
- •Patients currently participating in similar research studies.
结局指标
主要结局
Therapeutic adherence
时间窗: Through study completion, an average of 1 year.
Its evaluation will be carried out using the Haynes-Sackett test to determine therapeutic adherence vs. non-adherence (dichotomous qualitative variable) complemented with the Medication Possession Ratio (MPR), estimating a percentage (continuous quantitative variable). Good adherence is considered if the patient reports no difficulties in taking all their pills and has an MPR \> 80% for the 3 preventive drugs. Otherwise, it is considered poor therapeutic adherence. Poor therapeutic adherence is defined by the MPR if 20% or more of the prescribed packages have not been collected from the pharmacy in the last year. Poor adherence is determined if it is diagnosed by either method. As 3 drugs are analyzed, poor therapeutic adherence is considered if it occurs with any one of them, with two, or with all three. To evaluate therapeutic adherence, the Haynes-Sackett test will be administered, complemented by the MPR from the medical records.
次要结局
- Age(This variable will be collected prior to the start of the study.)
- Group(This variable will be collected prior to the start of the study.)
- Race(This variable will be collected prior to the start of the study.)
- Quality of life studied using the European Quality of Life-5 Dimensions(This variable will be collected prior to the start of the study.)
- Sex(This variable will be collected prior to the start of the study.)
- Educational level(This variable will be collected prior to the start of the study.)
- The Barthel index(This variable will be collected prior to the start of the study.)
研究者
Francisco Manuel Lidón Muñoz
Bachelor's in Medicine. PhD student.
Universidad Miguel Hernandez de Elche