The effect of therapeutic education on self-care in patients with heart failure and implantable cardioverter defibrillator: study protocol for a randomized controlled trial

Heart failure (HF) is a clinical syndrome caused by an abnormality of the cardiac structure or function, leading to the heart’s failure to deliver oxygen at a rate commensurate with the requirements of the metabolizing tissues, despite normal filling pressures (or only at the expense of increased filling pressures). It is estimated that there are 23,000,000 people affected by HF worldwide, with approximately 2-3% in the European population. HF is a condition that increases in prevalence with age, and affects more than 25% of the population aged –84 years old. It has been predicted that by 2030 there will be an increase of 25% in the number of people with HF. In Italy, where this study will be conducted, the prevalence of HF is between 1.1% and 1.4% of the general population. Mortality due to HF is high after diagnosis: the 30-day, 1-year and 4-year mortality rates are 12.1%, 28.8% and 61.4%, respectively. To reduce the burden of HF, self-care is considered a cornerstone in HF treatment. In fact, it was shown in previous studies that HF patients who perform adequate self-care may have fewer hospitalizations, better QOL and even lower mortality. However, patients struggle to perform adequate self-care and it was found not at adequate levels in several studies. One of the main causes of death in patients with HF is sudden cardiac arrest due to ventricular arrhythmia. To prevent this problem, international guidelines suggest the implantation of an implantable cardiac defibrillator (ICD) in HF patients who are more exposed to sudden cardiac death: ICD therapy is associated with significant reduction in mortality compared with antiarrhythmic drug therapy. While an ICD implantation can lead to important clinical benefits (e.g., the 20% reduction of deaths), this procedure can also determine new clinical issues in HF patients and greater need of self-care behaviors. Since it has been already found that self-care is poor in HF patients, it is important that HF patients with ICD undergo educational intervention to improve their level of self-care. 

The primary objective of this study will be to examine whether a nursing educational intervention based on therapeutic education can improve self-care in HF patients with recent implantations of ICD. The secondary objective will be to evaluate if a nursing educational intervention will improve quality of life in HF patients with ICD.

This is a multicenter, single blind, parallel-group study, which will involve two cardiovascular centers in northern Italy. The participant flowchart for the study is illustrated in Figure 1.