AnticoagulantsEDIANCT05710562
Epidemiological Description of Health Determinants in Italian Anticoagulated Population
An observational study of Anticoagulants, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anticoagulants
- What is being tested?
- Name not applicable
- Type of treatment
- Pill or oral medicine
- How many people
- 468 participants
- Where
- 1 siteItaly
- Study dates
- 5 Feb 2019to 4 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: According to the previous inclusion and exclusion criteria, this study will enroll patients treated chronically with oral anticoagulants nationally.
Who may be able to join
- Age greater or equal to18 years
- Outpatients
- Patients treated with oral anticoagulation therapy for at least three mounts
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Description of Health Determinants in Italian Anticoagulated Population (EDIA): a Cross-sectional and Multicenter Study Design
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.
Read the 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.
- Conditions
- Anticoagulants
- Being tested
- Name not applicable
- Keywords
- anticoagulation therapy, atrial fibrillation, international normalized ratio (INR), health determinants
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Name not applicableOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulated population | Adult patients under oral anticoagulation therapy Receives: Other: Name not applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (at the time of data collection)
Secondary outcomes (1)
Anticoagulation control
Time in therapeutic range (TTR%) in the last three months (for patients taking VKA therapy).
Measured: Day 1 (at the time of data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start5 Feb 2019
- Primary completion5 Feb 2025
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710562
- Sponsor's protocol ID
- 88/INT/2018
- Acronym
- EDIA
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32178684
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Description of Health Determinants in Italian Anticoagulated Population (EDIA): a Cross-sectional and Multicenter Study Design
- ClinicalTrials.gov ID
- NCT05710562
- Acronym / sponsor ID
- EDIA / 88/INT/2018
- Conditions
- Anticoagulants
- Keywords
- anticoagulation therapy, atrial fibrillation, international normalized ratio (INR), health determinants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticoagulated population | – | Other: Name not applicableAdult patients under oral anticoagulation therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- According to the previous inclusion and exclusion criteria, this study will enroll patients treated chronically with oral anticoagulants nationally.
Key inclusion criteria (3 listed)
- Age greater or equal to18 years
- Outpatients
- Patients treated with oral anticoagulation therapy for at least three mounts
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Name not applicableIn 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. | Other | Anticoagulated population |
Primary outcome
Anticoagulation knowledge
Time frame: Day 1 (at the time of data collection)
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.
Health literacy
Time frame: Day 1 (at the time of data collection)
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.
Quality of life (mental and physical wellbeing)
Time frame: Day 1 (at the time of data collection)
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.
General self-efficay
Time frame: Day 1 (at the time of data collection)
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.
Beliefs
Time frame: Day 1 (at the time of data collection)
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.
1 secondary outcome
Anticoagulation control
Time frame: Day 1 (at the time of data collection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 32178684Magon 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulants, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticoagulation knowledge (time frame: Day 1 (at the time of data collection)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.