Background: Self-care behavior is important in avoiding hospitalization for patients with heart failure (HF) and refers to those activities performed with the intention of improving or restoring health and wellbeing, as well as treating or preventing disease. The purpose was to study the effects of a home-based mobile device on self-care behavior and hospitalizations in a representative HF-population. Methods and Results: SMART-HF is a randomized controlled multicenter clinical trial, where patients were randomized 1:1 to receive standard care (control group [CG]) or intervention with a home-based tool designed to enhance self-care behavior (intervention group [IG]) and followed for 240 days. The tool educates the patient about HF, monitors objective and subjective symptoms and adjusts loop diuretics. The primary outcome is self-care as measured by the European Heart Failure Self-care behavior scale and the secondary outcome is HF related in-hospital days. A total of 124 patients were recruited and 118 were included in the analyses (CG: n = 60, IG: n = 58). The mean age was 79 years, 39% were female, and 45% had an ejection fraction of less than 40%. Self-care was significantly improved in the IG compared to the CG (median (interquartile range) (21.5 [13.25; 28] vs 26 [18; 29.75], p = 0.014). Patients in the IG spent significantly less time in the hospital admitted for HF (2.2 days less, relative risk 0.48, 95% confidence interval 0.32À0.74, P = .001). Conclusions: The device significantly improved self-care behavior and reduced in-hospital days in a relevant HF population.
Background A common heart failure (HF) aetiology is hypertension (HTN), second only to ischemic heart disease and with a prevalence in the HF community of between 62% and 84%, depending on sex and ejection-fraction. Undertreated HTN leads to worse prognosis and resistant HTN is defined as blood pressure (BP) exceeding 140/90 mmHg, in spite of pharmacological treatment. Since one constituent of self-care behaviour is treatment adherence, we wished to study whether patients exposed to a digital intervention shown to improve self-care behaviour, would also display improved BP control. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne in southern Sweden, where patients in the intervention group (IG) were equipped with a digital home-based tool, designed to enhance self-care behaviour for HF-patients and the control group (CG) were subject to standard care. BP data was registered at baseline and after eight months of intervention and self-care behaviour was measured using the European Heart Failure Self-care Behaviour Scale (EHFScB). We used a Chi-square test to analyse whether there was an inter-group difference of prevalence of resistant HTN or a mean arterial pressure (MAP) outside the recommended range of 60 mmHg < MAP <100 mmHg. Results Out of the 118 patients included in the original analysis, 92 (78%) had complete BP measurements. At baseline there was no difference in self-care behaviour between the groups, with CG: 25 [17.5; 32] and IG: 24.5 [18; 30], p=0.61, and 28% of the CG patients and 24% of the IG population displayed resistant HTN, p=0.73. After eight months of intervention the IG had 21% (or 4.5 points) better self-care behaviour compared to the CG, p=0.014, and the fraction of patients with resistant HTN was 30% for the CG and 11% for the IG, p=0.027. There was also a significant effect on the fraction of patients having a MAP >100 mmHg, with 22% in the CG versus 16% in the IG having MAP >100 mmHg at baseline (p=0.39) and 19% in the CG versus 0% in the IG at follow-up (p=0.002). Conclusions There was a significant improvement in self-care behaviour and also a significant reduction in the number of patients with resistant hypertension and elevated mean arterial pressure after eight months of intervention. Funding Acknowledgement Type of funding source: None
Background Clinical studies evaluating home-based interventions for heart failure (HF) patients are performed on patients that are too young, too often male and predominately have reduced ejection-fraction (EF). The Selfcare Management Intervention in Heart Failure (SMART-HF) study was designed to evaluate a digital intervention enhancing self-care behaviour in a more generalizable population. The aim was to see if the intervention could reduce in-hospital care due to HF. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne. Patients were randomized 1:1 to a control group (CG) receiving standard care or an intervention group (IG) who were equipped with the digital intervention. The intervention educates the patient about HF and supports the patient with medication and symptom monitoring, also notifying the patient in case of deterioration. The primary outcome was number of in-hospital days due to HF after 240 days follow-up. Results A total of 124 patients were randomized and 118 (CG: 60, IG: 58) were included in the analysis. The mean age was 79 years, 39% were women and 45% had EF <40%. The groups were well balanced at randomization. A total of 367 HF in-hospital days were registered among 33 patients, and patients in the IG lost on average 2.2 days fewer to HF-hospitalizations than patients in the CG, a reduction by 52%, p<0.001. An unadjusted Cox-regression to analyse the event-free survival yielded a hazard ratio = 0.50 (CI:0,24–0,96), p=0.046. The self-care behaviour was 21% better in the IG, p=0.014. The median system adherence was 85% after 240 days. Conclusions The intervention significantly reduced HF-related in-hospital days and improved event-free survival in a representative HF-population. The findings match previous published data from studies evaluating the same intervention. Funding Acknowledgement Type of funding source: None
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