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Search / Trial NCT05820854

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

Launched by IRCCS POLICLINICO S. DONATO · Apr 19, 2023

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how well patients can manage their own care while taking blood-thinning medications called oral anticoagulants (OAC). The goal is to create a tool, called the Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy (SCSE-OAC), which will help measure how confident patients feel in managing their treatment. The study will involve people who speak English and Italian and will check if the tool works well across different cultures.

To participate in this trial, individuals must be at least 18 years old, diagnosed with a specific type of irregular heartbeat called non-valvular atrial fibrillation, and have been taking OAC for at least three months. They should also be outpatients who are willing to sign consent to join the study. People who have taken OAC for less than three months, have serious health issues, recently stopped OAC for surgery, or have cognitive difficulties will not be eligible. Participants can expect to help develop a valuable tool that may improve care for others like them in the future.

Gender

ALL

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)

About Irccs Policlinico S. Donato

IRCCS Policlinico S. Donato is a leading Italian research hospital and clinical trial sponsor dedicated to advancing medical science through innovative research and patient care. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it is recognized for its commitment to high-quality clinical research and the integration of scientific investigation with clinical practice. The institution specializes in various medical fields, including cardiology, oncology, and neurology, and collaborates with universities and research organizations to facilitate cutting-edge studies. With a focus on improving patient outcomes and contributing to public health, IRCCS Policlinico S. Donato plays a pivotal role in the development of new therapies and treatment protocols.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported