NCT05820854

Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy

Patients' Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy (SCSE-OAC): A Bilingual/Multi-national Mixed-method Validation Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 312 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to develop and validate an index measurement tool to assess the patient's self-care self-efficacy in managing oral anticoagulation therapy (OAC). The index measure (i.e., SCSE-OAC) will be tested for its cross-cultural validity and reliability for the English and Italian-speaking population. For these reasons, a multi-phase and mixed-method observational and cross-sectional study design will be conducted.

Detailed description

Oral anticoagulation therapy (OAC) is the most suitable treatment worldwide for the primary and secondary prevention of thromboembolism and stroke in patients with non-valvular atrial fibrillation (NVAF). However, the strategies to provide an optimal quality of anticoagulation control are still an open challenge for healthcare professionals. In this regard, understanding the health determinants underline the patient's adherence is fundamental in the research field to develop personalized patient-centered education interventions in clinical practice and consequently avoid low treatment adherence. Among these health determinants (e.g., patients' knowledge, health literacy, beliefs, etc), the patients' self-efficacy is underreported because a specific tool is not yet available to measure patients' self-efficacy regarding the health behaviors challenges in OAC self-care management. The primary aim of this study is to develop the patients' self-care self-efficacy index in oral anticoagulation therapy management (SCSE-OAC) in adults with non-valvular atrial fibrillation and provide cross-cultural validity and reliability of the developed index measure. More specifically, to assess the internal validity of the SCSE-OAC, content and construct validity proprieties will be tested for each translated version of the SECSE-OAC, as well as its reliability and invariance characteristics.

Conditions

• Anticoagulants
• Self Efficacy
• Self Confidence

Interventions

Type	Name	Description
OTHER	Self-assess and reporting self-care self-efficacy levels	Patients will have to self-report the self-care self-efficacy levels they experienced in managing the OAC therapy.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-02-01
• Completion: 2025-02-01
• First posted: 2023-04-20
• Last updated: 2023-10-05