The Effects of Therapeutic Education on Self-care in Patients with Heart Failure and an Implantable Cardioverter Defibrillator: Study Protocol for a Randomised Controlled Trial
Journal Title: Biomedicine & Prevention - Year 2017, Vol 2017, Issue 2
Abstract
Background/Aims Therapeutic education has been shown to improve quality of life among patients with heart disease. However, little is known about the effects of therapeutic education on self-care in patients with heart failure (HF) during the follow-up period after the implantation of an implantable cardioverter defibrillator (ICD). Therefore, the aim of this study is to examine the effects of therapeutic education on improving self-care in HF patients with ICD. The secondary objectives are as follows: 1) to evaluate the impact of a nursing educational intervention on the quality-of-life perception at all follow-up visits; 2) to investigate the prognostic role of the educational programme for HF patients at 12 months; and 3) to determine whether therapeutic education leads to resource savings for the healthcare system and, in turn, to a generally lower burden on citizens and society at all follow-up visits. Methods A multi-centre, single-blind, parallel-group randomised trial will be conducted in Italy. A sample of 128 patients hospitalised for ICD implantation will be randomly assigned to the intervention group or the control group. The intervention group will undergo therapeutic education during the first follow-up (7 ± 3 days from implantation) and at the successive follow-ups (3, 6 and 12 months). Therapeutic education will focus on 1) pharmacological adherence, weight monitoring, diet, smoking, alcohol, work activity and sexual activity; 2) signs of dyspnoea, how to identify oedema through the fovea and how to recognise rapid weight gain, appetite loss, fatigue, asthenia, insomnia and mental confusion; and 3) recognition of the symptoms of inflammation at the surgical implantation site. At each follow-up (3, 6 and 12 months), the patient will undergo an electrocardiogram and blood tests (blood panel and tests to measure brain natriuretic peptide, renal function, indices of hepatobiliary stasis and serum protein parameters). The primary goal of this study is to examine whether a nursing educational intervention can improve self-care (measured by the Self-Care Heart Failure Index) in HF patients with recent ICD implantation at the 12-month follow-up. Conclusion The results of this study will enhance knowledge about self-care and the effects of nursing education on patient satisfaction and possible economic savings. This project can be a starting point for future research on a larger number of participants with HF treated with ICDs.
Authors and Affiliations
Angela Durante, Raúl Juárez-Vela, Michela Luciani, Sebastiano Marra, Ferdinando Varbella, Federica Rossi, Riccardo Sperlinga, Maria Michela Gianino
Keywords
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- EP ID EP335043
- DOI 10.19252/000000064
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