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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-valvular atrial fibrillation (NVAF) patients treated with oral anticoagulants | Adult outpatients (≥ 18 years) with NVAF and treated with OAC for at least three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-assess and reporting self-care self-efficacy levels | Other | Patients will have to self-report the self-care self-efficacy levels they experienced in managing the OAC therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| SCSE-OAC index | The SCSE-OAC measurement index will provide evidence about the level patients perceive in their skills in facing daily challenges in managing their oral anticoagulation therapy. Furthermore, evidence of the validity and reliability of the SCSE-OAC tool will be provided for each native-speaking country involved in the study. | data collection will perform at the first 1 day patient visit |
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Inclusion Criteria:
Exclusion Criteria:
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Each native-speaking country involved in the study will select a convenience sample of adult non-valvular atrial fibrillation patients (NVAF) chronically treated with oral anticoagulants.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arianna Magon | Contact | 3313812318 | arianna.magon@grupposandonato.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39269742 | Derived | Magon A, Hendriks J, Caruso R. Developing and Validating a Self-Care Self-Efficacy Scale for Oral Anticoagulation Therapy in Patients With Nonvalvular Atrial Fibrillation: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Sep 13;13:e51489. doi: 10.2196/51489. | |
| 38267024 | Derived | Magon A, Hendriks JM, Conte G, Caruso R. Description of self-care behaviours in patients with non-valvular atrial fibrillation on oral anticoagulant therapy: a scoping review. Eur J Cardiovasc Nurs. 2024 Sep 5;23(6):582-591. doi: 10.1093/eurjcn/zvae007. |
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