Progression of atrial fibrillation (AF) and outcomes of ablation therapy are strongly affected by modifiable risk factors. Although previous studies show beneficial effects of modifying single risk factors, there is lack of evidence from randomized controlled trials on the effects of integrated AF lifestyle programmes. The POP trial is designed to evaluate the clinical outcomes of a dedicated nurse-led AF lifestyle outpatient clinic in patients with symptomatic AF. This study is a prospective, 1:1 randomized, single centre, investigator-initiated clinical trial in 150 patients with paroxysmal or persistent AF referred for a first pulmonary vein isolation (PVI). Prior to the ablation, patients in the intervention group receive a personalized risk factor treatment programme in a specialized, protocolized, nurse-led outpatient clinic. Patient education and durable lifestyle management is promoted with an e-health platform. Patients in the control group receive standard care by cardiologists before ablation. The primary endpoint is the number of hospitalizations for re-ablation and cardioversion, with a follow-up of 12 months after ablation. Secondary endpoints include mortality, number of acute ischemic events, stroke or hospitalizations for heart failure, quality of life, number of ablations cancelled because of symptom reduction, and ablation success rate at 12 months. Determinants of patient and staff experience are explored and a cost-effectiveness analysis is included. The POP trial will help ascertain the efficacy and cost-effectiveness of an integrated technology-supported lifestyle therapy in patients with symptomatic AF. The trial is funded by the Netherlands Organisation for Health Research and Development [10070012010001]. Home sleep apnoea testing devices were provided by Itamar Medical, Ltd.ClinicalTrials.gov Identifier NCT05148338. Graphical abstract AF atrial fibrillation, OSA obstructive sleep apnoea, PFA pulsed field ablation, PVI pulmonary vein isolation.
Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): the Netherlands Organisation for Health Research and Development (ZonMw). Background Atrial Fibrillation (AF) symptom management can be challenging with current treatment strategies. Most risk factors for AF are related to lifestyle and therefore, healthy behaviour among AF patients can improve treatment outcomes. Behaviour change techniques and an integrated care approach have been demonstrated to effectively reduce cardiovascular hospitalisation in AF patients. Furthermore, involving patients in healthcare decision making increases patient participation and improves treatment outcomes. However, needs and perceptions of patients on an AF specialised outpatient clinic have not been studied yet. Patient behaviour can be explained with the Integrated Behavioural Model. This model theorizes that the strongest predictor in behaviour is behavioural intention, which is affected by determinants such as attitude, perceived norm and personal agency. These determinants can be used to understand and influence behaviour. Therefore, the Integrated Behavioural Model attributes to gather insights into patients’ perspectives and needs and may improve AF treatment outcomes. Purpose This study aims to identify patients’ needs and perceptions regarding a specialised AF outpatient clinic, to identify essential aspects required for behaviour change techniques to modify important AF risk factors, and to explore the role of the nurse practitioner in risk factor management. Methods Study participants were recruited at the specialised AF outpatient clinic of a third-line hospital. Semi-structured interviews were conducted using an interview guide that included topics described in scientific literature regarding risk factor modification and the integrated Behavioural Model. Additionally, perceptions regarding a lifestyle oriented AF outpatient clinic were asked. Transcripts were analyzed using a thematic analysis. Results A total of 11 patients were recruited. Qualitative analysis resulted in three main themes: AF symptoms and treatment, current lifestyle behaviours, and expectations for a specialised outpatient clinic. Overall, patients indicated to experience multiple complaints related to AF despite medical therapy and 64% confirmed that AF impairs their Quality of Life. Inadequate knowledge about AF, anxiety, and a worsened stamina are important barriers to execute a healthy lifestyle. Nonetheless, determinants such as social norm facilitate healthy behaviour. In order to improve their lifestyle, patients highlighted they prefer easy accessible health professionals who guide them in symptom management, increase their knowledge about AF and its risk factors, and to improve their lifestyle. Conclusion This study confirms that health professionals are important facilitators to increase healthy lifestyle among AF patients. Greater emphasis should be given to an integrated, multidisciplinary care approach to develop a comprehensive intervention programme aimed at changing unhealthy behaviour.
Aim To validate the predictive value of the European coLlaboration on Acute decompeNsated Heart Failure (ELAN-HF) score, and to assess the effect of self-care behaviour on readmission and mortality in patients after admission with acute decompensated heart failure (ADHF). Design Quantitative, prospective, single centre, cohort study. Methods N-Terminal pro–B-type natriuretic peptide (NT-proBNP) levels were measured on admission and discharge, and were used together with clinical and laboratory parameters to calculate the ELAN-HF score. Patients were stratified into four risk groups (low, intermediate, high, very high) according to their ELAN-HF score. The performance of the ELAN-HF score was evaluated and compared to the original study. Self-care behaviour was assessed by the European Heart Failure Self-care Behaviour Scale (EHFScBS-9). Survival analysis was used to estimate the association between both scores and re-admission for HF and/or all-cause mortality within 180 days. Results 88 patients were included. The median age of the study population was 75 years (IQR 69–83), 43% was female. NYHA III/IV functional class was present at discharge in 68 patients (85%) and 27 patients (34%) had a left ventricular ejection fraction < 40%. Complete data and 180 day follow up was available for 80 patients. 55% reached the endpoint of readmission and/or all-cause mortality. There was a significant association between the ELAN-HF score and re-admission and/or mortality < 180 days (HR = 1.25, 95% CI 1.08—1.45, p = 0.003). The median EHFScBS-9 score was 68.1 (IQR 58.3 – 77.8). There was no significant association between the EHFScBS-9 score and readmission and/or mortality < 180 days (HR = 1.01, 95% CI 0.99—1.03, p = 0.174). Conclusion This study confirms the validity and therefore the potential of the ELAN-HF score to triage patients with ADHF before discharge. Using this score may optimize the follow-up treatment on the nurse-led heart failure clinic in order to decrease readmission and mortality. Self-care behaviour was non-significantly associated with readmission and/or mortality in our study population. Trial Registration This study has been registered with the ethics committee MEC-U (Nieuwegein, The Netherlands), registration nr: V.160999/W18.208/HG/mk.
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