Home Based Education and Learning Program in Atrial Fibrillation Rationale and design of the HELP-AF Study

Abstract Background Atrial fibrillation (AF) is a growing global epidemic with its prevalence expected to significantly rise over coming decades. AF poses a substantial burden on health care systems largely due to hospitalizations. Home-based clinical characterization has demonstrated improved outcomes in cardiac populations but its impact on AF remains poorly defined. To test this hypothesis in AF, we developed the Home-based Education and Learning Program in patients with Atrial Fibrillation (HELP-AF) study. Methods The HELP-AF study is a prospective, multi-centre randomized controlled trial that will recruit 620 patients presenting to hospital emergency departments (ED) with symptomatic AF (ANZCTR Registration: ACTRN12611000607976). Patients will be randomized to either the HELP-AF intervention or usual care. The intervention consists of two home visits by a nurse or pharmacist trained in the Structured Educational Visiting (SEV) method. Patients in the control group will receive usual discharge follow-up care. Results The primary endpoints are (i) total unplanned hospital admissions and (ii) quality of life. Secondary endpoints include AF symptom severity and burden score, time to first hospital admission and at least one hospital admission, total unplanned days in hospital, total AF-related hospital admissions (including Atrial Flutter), total cardiac and non-cardiac hospital admissions, total AF or Atrial Flutter related, cardiac and non-cardiac related ED presentations, and all-cause mortality. An economic evaluation will also be performed. Clinical endpoints will be adjudicated by independent blinded assessors. Follow-up will be 24 months. Conclusions This study will assess the efficacy of a home-based structured patient-centred educational intervention in AF patients.