Clinical trial NCT05710562: Epidemiological Description of Health Determinants in Italian Anticoagulated Population
Official title: Epidemiological Description of Health Determinants in Italian Anticoagulated Population (EDIA): a Cross-sectional and Multicenter Study Design
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulants
Keywords: anticoagulation therapy
atrial fibrillation
international normalized ratio (INR)
health determinants
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 1495
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: Oral Anticoagulation Therapy (OAC) is the leading therapeutic choice in treating and preventing diverse cardiovascular diseases, such as non-valvular atrial fibrillation and venous thromboembolism. Therefore, several empirical studies inquired on which are the main health determinants involved in promoting therapeutic adherence and well-being in the population affected by chronic disease. However, few studies tested the effect of the health determinants on anticoagulation control in reducing thromboembolic and hemorrhagic complications.

The majority of these studies focused their attention on the knowledge level assessment, which results to be a positive predictor of adequate treatment adherence. Moreover, the same knowledge is predicted by adequate Health Literacy (HL). Nevertheless, the disease patients' knowledge results to be generally very low, as well as the levels of HL and treatment adherence behaviors. Furthermore, patients are often unaware of how the drug works, their possible interactions, and side effects, and they often perceive a low quality of life. Indeed, it is not easy to summarize the available evidence because studies' results are often not comparable, considering the diverse measurements to assess the same theoretical constructs. Those measurements, in some cases, also present weaknesses in psychometric evidence of validity and reliability. Finally, the effects of some constructs, how self-efficacy and self-care, are still unexplored.

In light of these considerations, currently, nobody of these health determinants has been studied in the Italian anticoagulated population through the best available tools. The results coming from this study may lead to a more depth awareness of which are the main needs of those patients to reach good anticoagulation control, allowing healthcare providers to better address the personalized educational interventions aimed to improve the skills of patients in clinical decision-making on their own health condition.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Anticoagulation knowledge
timeFrame: Day 1 (at the time of data collection)
measure: Health literacy
timeFrame: Day 1 (at the time of data collection)
measure: Quality of life (mental and physical wellbeing)
timeFrame: Day 1 (at the time of data collection)
measure: General self-efficay
timeFrame: Day 1 (at the time of data collection)
measure: Beliefs
timeFrame: Day 1 (at the time of data collection)
Secondary outcomes:
measure: Anticoagulation control
timeFrame: Day 1 (at the time of data collection)
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
Study officials:
References:
citation: 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.