INFORM-AF II-Phase 1 pilot randomised controlled trial evaluating the effect of an atrial fibrillation digital education programme: study protocol.

ABSTRACT

AIM: To evaluate the effect of a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce re-hospitalisation of people with AF. The secondary aims are to examine the effect of the intervention on (a) reducing cardiovascular-related hospitalisation, (b) increasing medication adherence, AF-related knowledge, and Atrial fibrillation (AF)-related quality of life and (c) determining the cost-effectiveness of the intervention. BACKGROUND: AF is an increasingly prevalent cardiac arrythmia that involves complex clinical management. Comprehensive education is essential for successful self-management of AF and is associated with positive health-related outcomes. There has been an increase in technology-based education for AF. However, its effects on hospitalisation, medication adherence and patient-reported outcomes are unclear. DESIGN: A prospective, randomised (11), open-label, blinded-endpoint, multicentre clinical trial. METHODS: Eligible participants are aged 18 years or above, diagnosed with AF, and own a smartphone. The study will be conducted at two metropolitan hospitals. In the intervention group, participants will receive the AF educational program delivered via Qstream®. In the control group, participants will receive the Stroke Foundation 'Living with AF' booklet. The primary outcome is re-hospitalisation within 12 months from an indexed presentation or hospital admission. CONCLUSION: This clinical trial is part of a developing program of work that will examine mHealth educational-behavioural interventions on cardiovascular outcomes. Findings from this pilot study will inform the development of a digital educational framework for patients living with AF. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE There remain many gaps in providing high-quality patient education for patients with AF. This trial will test a new theory-driven, smartphone-based education program on important clinical outcomes, including rehospitalisation. IMPACT This study evaluates a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce the re-hospitalisation of people with AF. Study results are expected to be reported in 2025. Findings are expected to inform practice recommendations for AF patient education that may be included in future clinical practice guideline recommendations. REPORTING METHOD: SPIRIT Checklist. PATIENT OR PUBLICATION CONTRIBUTION JL is a consumer co-researcher on the project and provided critical input into intervention design, and feedback and input across the study duration.