Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy (SCSE-OAC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Self Efficacy; Self Confidence; Anticoagulants
• Intervention / Treatment: Other: Self-assess and reporting self-care self-efficacy levels

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.

• Study Type: Observational
• Enrollment (Estimated): 312

Contacts and Locations

• Study Contact: Name: Arianna Magon; Phone Number: 3313812318; Email: arianna.magon@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 164/INT/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No