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

NCT05820854 | Unknown DMC

• 1 other identifier: 164/INT/2022
• Study Type: observational
• Target: 312
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anticoagulants; Self Efficacy; Self Confidence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

Non-valvular atrial fibrillation (NVAF) patients treated with oral anticoagulants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Related Publications (2)

• 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.

  PMID: 39269742 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.

  PMID: 38267024 DERIVED

Central Study Contacts

Arianna Magon

CONTACT

3313812318; arianna.magon@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 20, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share