Assessing Preparedness for Self-Management of Oral Anticoagulation in Adults With the PERSONAE Scale: Protocol for a Development and Validation Study.

Background: Optimal anticoagulation using vitamin K antagonists prevents strokes associated with atrial fibrillation and heart valve replacements. Preparedness for self-monitoring and self-management could improve outcomes, but this remains a challenge.

Objective: This study aimed to outline the methodology for developing and validating the PERSONAE scale, a self-report measure designed to assess the preparedness for self-monitoring and self-management of oral anticoagulation in adult patients.

Methods: This study comprises 2 main phases, and it adheres to the "COnsensus-based Standards for the selection of health Measurement INstruments" (COSMIN) guidelines for instrument development. The first phase involved the conceptualization of the PERSONAE scale, where a comprehensive literature review and a consensus meeting among experts were conducted to draft the initial items. Face and content validity were then established through an expert panel review. In the second phase (ongoing), a detailed sampling methodology will be used, targeting adult Italian patients on long-term oral anticoagulation. According to a performed simulation-based power analysis, the study aims to recruit a sample size of approximately 500 participants by using a combination of convenience and snowball sampling. Data collection will be facilitated through web-based surveys distributed through social media and patient networks, ensuring a wide and representative sample. Analytical procedures will include Mokken scaling analysis for item selection and confirmatory factor analysis to validate the scale's structure. In addition, internal consistency will be assessed using Molenaar Sijtsma statistics.

Results: The scale's content derived from phase 1 (process completed in December 2023) is grounded in a comprehensive literature review and based on the assessments of a panel of 12 health care expert professionals. The PERSONAE scale derived from phase 1 encompasses 20 items reflecting essential behaviors needed to assess the preparedness for self-monitoring and self-management of oral anticoagulation. Each item obtained a content validity ratio higher than 0.67, which is the critical content validity ratio indicating the minimum level of agreement among the experts for an item to be considered essential beyond the level of chance at a significance level of .05 for a 1-tailed test. From January 2024 to May 2024, we conducted the initial round of data collection and use Mokken scaling analysis to select items. A second round of data collection for confirmatory factor analysis was scheduled from June 2024 to September 2024, which will validate the scale's unidimensional structure. We expect to achieve robust psychometric properties, including high internal consistency and validated constructs.

Conclusions: The PERSONAE scale will be a valuable tool to assess patients' preparedness for self-monitoring and self-management of oral anticoagulation. The study's insights into technology-assisted learning preferences will inform the design of future educational interventions to enhance preparedness in adult patients.

Trial registration: ClinicalTrials.gov NCT05973240; https://clinicaltrials.gov/study/NCT05973240.

International registered report identifier (irrid): PRR1-10.2196/51502.