Patients with atrial fibrillation (AF) play passive roles in disease management. This study aimed to examine the feasibility and preliminary effects of an empowerment-based care model, titled 'the nurse-led multi-component behavioural activation (N-MBA) programme', on health-related quality of life, AF knowledge, psychological outcomes, medication adherence, and treatment decision-making in patients with AF. This mixed-methods study comprised a pilot randomized controlled trial and a qualitative study. Patients with AF who had a moderate-to-high risk of stroke but were not prescribed oral anticoagulants were recruited. Forty participants were recruited and randomized in a 1:1 ratio to receive either the N-MBA programme or standard care. The 13-week programme comprised care components that prepared patients for shared decision-making, an empowerment-based educational module on AF self-care, and continuous support through telephone calls. The programme was feasible, and the overall attendance rate was 82.5%. The participants gave excellent ratings in the satisfaction survey. The N-MBA group showed greater improvements in health-related quality of life (HRQoL) and AF knowledge than the standard care group at the immediate post intervention and 6-month follow-up time points. No significant between-group changes in medication adherence, anxiety, and depression were detected. Participants in the N-MBA group actively raised concerns about AF and its treatment with their attending doctors. The qualitative data were consistent with the quantitative data, indicating that the programme built a comprehensive knowledge base of AF and self-care behaviours. The N-MBA programme is feasible and acceptable to patients with AF. It improved patients' AF knowledge, treatment-related decision-making, and HRQoL. ClinicalTrials.gov NCT03924739.
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