Introduction: Guidelines have recognized the critical role of self-care in heart failure (HF), but people with HF do not adequately practice self-care. The Common-Sense Model (CSM) of Self-Regulation is a widely used theoretical framework for promoting behavior change and improving disease prognosis among patients. However, studies on the effects of the application of this model among people with HF are limited and present mixed results. Aims: To examine the effects of a nurse-led CSM of Self-Regulation-based self-care intervention on illness perceptions, self-care behaviors, self-care self-efficacy, self-care behaviors, health-related quality of life, depression, anxiety, symptom burden, sleep quality, healthcare service utilization, and mortality among people with HF. Methods: A randomized controlled trial was conducted. Participants were recruited from a university-affiliated hospital and randomized at a 1:1 ratio into the intervention or the control groups. Participants in the intervention group received a 6-week nurse-led CSM of Self-Regulation-based self-care program and usual care. Control group participants only received the usual care. Outcomes of interest were measured at baseline, 6 weeks (T1), and 3 months (T2) after enrollment. The generalized estimating equations model and Mann-Whitney U test were used to examine the intervention effects on the study outcomes. Results: 138 subjects were enrolled in the study between March and May 2023. Participants in the intervention showed statistically greater improvements in illness perceptions, self-care self-efficacy, self-care behaviors, health-related quality of life, depression, symptom burden, and sleep quality compared with the controls at T1 and T2. We also observed a statistically significant reduction in the number of HF-related unscheduled outpatient department visits in the intervention group compared to the control group at T2. However, no significant differences were found in anxiety, number of HF-related hospital readmissions, length of HF-related hospital stays, number of HF-related emergency department visits, or HF-related mortality between the study groups at T1 and T2. Conclusion: Our program generates favorable effects on promoting behavior change and improving health outcomes among people with HF. It also fills the knowledge gaps around the application of CSM of Self-Regulation in people with HF and provides more empirical evidence supporting the effectiveness of nurse-led interventions.
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