Clinical trial NCT05820854: Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy
Official title: Patients' Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy (SCSE-OAC): A Bilingual/Multi-national Mixed-method Validation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anticoagulants
Self Efficacy
Self Confidence
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of non-valvular atrial fibrillation
* Outpatients
* Treating with any OAC for at least three months before enrollment
* Patients willing to participate in the study and provide informed consent

Exclusion Criteria:

* Patients treated with OAC for a brief period (i.e., less than three months)
* Patients with serious comorbidity (i.e, Charlson Comorbidity Index, ICC \> 4)
* Patients who have suspended OAC for surgery in the last three months
* Cognitive impairment (assessed using six-item screener, SIS \< 4)

Primary outcomes:
measure: SCSE-OAC index
timeFrame: data collection will perform at the first 1 day patient visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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