Developing and Validating a Self-Care Self-Efficacy Scale for Oral Anticoagulation Therapy in Patients with non-valvular atrial fibrillation: Rationale, Design, and Methodology of a Multi-National Mixed-Methods Study (Preprint)

Abstract

Oral anticoagulation therapy (OAC) is the cornerstone treatment for preventing venous thromboembolism and stroke in patients with non-valvular atrial fibrillation (NVAF). However, low adherence and persistence to OAC have been reported, potentially leading to severe complications. Patients’ self-efficacy plays a significant role in medication adherence, but a specific tool to measure self-efficacy related to OAC self-care management is lacking. This study aims to develop and validate the Patients’ Self-Care Self-Efficacy Index in Oral Anticoagulation Therapy Management (SCSE-OAC) for English and Italian-speaking populations.

The primary aim is to develop and validate the SCSE-OAC to assess patients’ self-efficacy in managing OAC treatment. The secondary aim is to describe patients’ self-care self-efficacy levels in OAC management for each native-speaking group involved in the study and explore associations with socio-demographic or clinical variables.

A multi-phase and mixed-method observational study will be conducted. In the conceptualization phase, a preliminary item pool for SCSE-OAC will be developed through a literature review, patient focus groups, and expert consensus. In the validation phase, content validity will be assessed through patient and expert evaluations. Construct validity will be evaluated using exploratory and confirmatory factor analyses, ensuring cross-cultural validity between English and Italian versions. Criterion validity will be assessed using clinical variables related to anticoagulation control. Reliability will be tested through internal consistency and test-retest reliability.

The study will involve adult outpatients with NVAF treated with OAC for at least three months. Data will be collected prospectively through e-surveys and paper forms. A sample size of approximately ten patients per item and per language group will be used for each factor analysis. Data analysis will involve structural equation modeling, multi-group confirmatory factor analysis, and reliability testing.

The SCSE-OAC will provide a specific and comprehensive tool to measure patients’ self-efficacy in OAC self-care management. Validating the index in English and Italian-speaking populations will enable personalized patient-centered educational interventions, ultimately improving OAC treatment outcomes.

ClinicalTrials.gov: NCT05820854