Home-based education and learning program for 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 for Patients With Atrial Fibrillation (HELP-AF) study. METHODS:The HELP-AF study is a prospective multicentre randomized controlled trial that will recruit 620 patients presenting to hospital emergency departments (EDs) with symptomatic AF (ANZCTR Registration: ACTRN12611000607976). Patients will be randomized to either the HELP-AF intervention or usual care. The intervention consists of 2 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 total unplanned hospital admissions and quality of life. Secondary endpoints include AF symptom severity and burden score; time to first hospital admission; total unplanned days in hospital; total AF-related hospital admissions (including atrial flutter); total cardiac and noncardiac hospital admissions; total AF- or atrial flutter-related; cardiac- and noncardiac-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 at 24 months. CONCLUSIONS:This study will assess the efficacy of a home-based structured patient-centred educational intervention in patients with AF.