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

Self Efficacy Clinical Trial

— SCSE-OAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05820854
• Other study ID #: 164/INT/2022
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Arianna Magon
• Phone: 3313812318
• Email: arianna.magon[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 312
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anticoagulants
• Self Efficacy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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