Epidemiological Description of Health Determinants in Italian Anticoagulated Population

NCT05710562 | Unknown DMC

• 1 other identifier: 88/INT/2018
• Study Type: observational
• Target: 1,495
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to describe and develop a cross-sectional profile of the level of the main health determinants in the Italian anticoagulated population (disease knowledge; self-efficacy; health literacy; quality of life). Indeed, evaluate how socio-demographic and clinical data may affect the same relations. Furthermore, the secondary aim is to describe relationships between health determinants and anticoagulation control (i.e., Time in Therapeutic Range, TTR%, or absence of clinical complications). To evaluate the impact of socio-demographic and clinical data on the relationship between health determinants and anticoagulation control.

Conditions

Anticoagulants

Keywords

anticoagulation therapy; atrial fibrillation; international normalized ratio (INR); health determinants

Outcome Measures

Primary Outcomes (5)

• Anticoagulation knowledge

  This outcome will be measured through the Anticoagulation Knowledge tool: a self-report tool to assess the general anticoagulation knowledge for any OAC treatment. Higher level scores indicate better knowledge.

  Day 1 (at the time of data collection)

• Health literacy

  This outcome will be measured through the Health Literacy Questionnaire: a self-report and multi-dimensional tool assess HL at functional, communicative/interactive, and critical levels. These dimensions provide an assessment of how the person understand access to and use of health information and health services. The final score is computed for each sub-scale and higher levels indicate better health literacy levels.

  Day 1 (at the time of data collection)

• Quality of life (mental and physical wellbeing)

  This outcome will be measured through the Short form survey: a self-report tool to assess physical and mental health. The score is computed for each domain (physical and mental health) and higher levels indicate better quality of life perception.

  Day 1 (at the time of data collection)

• General self-efficay

  This outcome will be measured through the General Self-Efficacy Scale: a self-report tool to assess the level of a personals confidence to do something. The general score ranged between 0 to 100 and higher levels indicate better general self-efficacy.

  Day 1 (at the time of data collection)

• Beliefs

  This outcome will be measured through the Beliefs about Medicines Questionnaire: a self-report tool to assess the patient's beliefs and attitudes on the necessity and concerns of drug prescription. The final score is computed for each domain.

  Day 1 (at the time of data collection)

Secondary Outcomes (1)

• Anticoagulation control

  Day 1 (at the time of data collection)

Study Arms (1)

Anticoagulated population

Adult patients under oral anticoagulation therapy

Other: Name not applicable

Interventions

Name not applicable OTHER

In this study, we do not provide any type of intervention but only require the fulfillment of self-report tools by patients during their routine outpatients visit.

Anticoagulated population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the previous inclusion and exclusion criteria, this study will enroll patients treated chronically with oral anticoagulants nationally.

You may qualify if:

• Age greater or equal to18 years
• Outpatients
• Patients treated with oral anticoagulation therapy for at least three mounts

You may not qualify if:

• Patients treated with oral anticoagulant therapy for a brief period (i.e., treatment \< 6 months)
• Patients with severe comorbidity (i.e., Charlson Comorbidity Index, ICC \> 4)
• Patients who have suspended oral anticoagulation therapy for surgery in the last three months
• Cognitive impairment (assessed using a six-item screener)

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

Related Publications (1)

• Magon A, Arrigoni C, Moia M, Mancini M, Dellafiore F, Manara DF, Caruso R. Determinants of health-related quality of life: a cross-sectional investigation in physician-managed anticoagulated patients using vitamin K antagonists. Health Qual Life Outcomes. 2020 Mar 16;18(1):73. doi: 10.1186/s12955-020-01326-y.

  PMID: 32178684 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arianna AM Magon, PhD

CONTACT

+39 0252774940; arianna.magon@grupposandonato.it

Rosario RC Caruso, PhD

CONTACT

+39 0252774940; rosario.caruso@grupposandonato.it

Study Design

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

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: February 5, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)