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Efficacy of an intervention to increase therapeutic adherence in patients with secondary prevention for
Francisco Manuel Lidón-Muñoz1, José Antonio Quesada2,3,4, Vicente Francisco Gil-Guillén2,3,4
1Dr. Balmis General University Hospital of Alicante, Babel Health Centre, Alicante, Spain.
Insights
Improving medication adherence in cardiovascular disease patients is vital. A health education intervention based on the Chronic Care Model shows promise for enhancing adherence to essential preventive drugs.
Area of Science:
- Cardiology
- Public Health
- Health Education
Background:
- Cardiovascular diseases (CVD) are the leading global cause of mortality.
- Secondary prevention strategies, including antihypertensives, statins, and aspirin, are crucial but face significant adherence challenges.
- Non-adherence to prescribed medications is prevalent, particularly in primary care settings, leading to increased morbidity, mortality, and healthcare costs.
Purpose of the Study:
- To evaluate the efficacy of a health education intervention, utilizing the Chronic Care Model, in improving adherence to three key preventive drugs in patients undergoing cardiovascular secondary prevention.
- To address the critical issue of therapeutic non-adherence in high-risk CVD patients.
Main Methods:
- An open-label, randomized controlled trial with 45 patients per group (intervention and control).
- Patients were selected via consecutive non-probability sampling and randomly assigned using a random number table.
- The study involved a 1-year follow-up period, with univariate, bivariate, and multivariate analyses planned for data assessment.
Main Results:
- The study hypothesizes an increase in therapeutic adherence from 50% in the control group to 80% in the intervention group.
- Statistical power is set at 80% with a 5% type I error rate.
- A 15% loss to follow-up was accounted for in the sample size calculation.
Conclusions:
- If successful, the intervention offers a feasible approach to enhance medication adherence in primary care for CVD secondary prevention patients.
- Improved adherence can significantly mitigate the negative consequences of non-adherence, such as increased morbidity and mortality.
- This intervention holds substantial public health implications for managing a leading cause of death worldwide.
Introduction:
Cardiovascular diseases represent the leading cause of mortality worldwide. This category includes cerebrovascular disease, ischemic heart disease, and peripheral vascular disease. Secondary prevention is effective for patients with a history of cardiovascular events, with antihypertensives, statins, and acetylsalicylic acid being the most prescribed drugs. Therapeutic adherence is crucial, as the lack of it increases morbidity, mortality, reduces quality of life, and raises healthcare costs. However, less than half of patients adhere to all three drugs within the first year post-event. Furthermore, non-adherence is more pronounced in primary care.
Objective:
Based on our hypothesis that in patients undergoing cardiovascular secondary prevention, an intervention grounded in the application of the Chronic Care Model improves adherence to the three preventive drugs, this study aims to evaluate the efficacy of a health education intervention, which implements this model, to increase adherence in patients with cardiovascular disease.
Methods:
An open-label randomized controlled trial will be conducted, selecting patients who meet inclusion criteria through consecutive non-probability sampling. Random assignment will be performed using the random number table method. Based on a therapeutic adherence rate of 50% in the control group and 80% in the intervention group, with a type I error of 5% (95% confidence interval), a type II error of 20% (80% power), and accounting for a 15% loss to follow-up, the final sample size will be of 45 patients per group. Follow-up will last for 1 year. Following data collection, univariate, bivariate, and multivariate analyses will be performed to isolate confounding factors and assess the intervention's impact on adherence.
Discussion:
If the results obtained in this study are favorable and the intervention is successful in enhancing therapeutic adherence, its applicability would be substantial, representing a feasible intervention for implementation in primary care. This approach addresses a significant public health issue, namely the lack of therapeutic adherence and its associated consequences. Moreover, this is particularly pertinent for high-risk patients, such as those in secondary prevention, given that cardiovascular disease remains the leading cause of mortality in developed countries. This trial has been registered at clinicalTrials.gov, https://clinicaltrials.gov/study/NCT06510946.
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