AnticoagulantsSCSE-OACNCT05820854
Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy
An observational study of Anticoagulants and Self Efficacy, run by IRCCS Policlinico S. Donato.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anticoagulants, Self Efficacy, Self Confidence
- What is being tested?
- Self-assess and reporting self-care self-efficacy levels
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Patients' Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy (SCSE-OAC): A Bilingual/Multi-national Mixed-method Validation Study
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.
Read the detailed description
Oral anticoagulation therapy (OAC) is the most suitable treatment worldwide for the primary and secondary prevention of thromboembolism and stroke in patients with non-valvular atrial fibrillation (NVAF). However, the strategies to provide an optimal quality of anticoagulation control are still an open challenge for healthcare professionals. In this regard, understanding the health determinants underline the patient's adherence is fundamental in the research field to develop personalized patient-centered education interventions in clinical practice and consequently avoid low treatment adherence. Among these health determinants (e.g., patients' knowledge, health literacy, beliefs, etc), the patients' self-efficacy is underreported because a specific tool is not yet available to measure patients' self-efficacy regarding the health behaviors challenges in OAC self-care management.
The primary aim of this study is to develop the patients' self-care self-efficacy index in oral anticoagulation therapy management (SCSE-OAC) in adults with non-valvular atrial fibrillation and provide cross-cultural validity and reliability of the developed index measure.
More specifically, to assess the internal validity of the SCSE-OAC, content and construct validity proprieties will be tested for each translated version of the SECSE-OAC, as well as its reliability and invariance characteristics.
- Conditions
- Anticoagulants, Self Efficacy, Self Confidence
- Being tested
- Self-assess and reporting self-care self-efficacy levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-assess and reporting self-care self-efficacy levelsOther
Patients will have to self-report the self-care self-efficacy levels they experienced in managing the OAC therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-assess and reporting self-care self-efficacy levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: data collection will perform at the first 1 day patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study startNov 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arianna Magon, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820854
- Sponsor's protocol ID
- 164/INT/2022
- Acronym
- SCSE-OAC
- Status last verified
- Oct 2023
- First submitted
- 5 Apr 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39269742Magon 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.
PubMed 38267024
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy (SCSE-OAC): A Bilingual/Multi-national Mixed-method Validation Study
- ClinicalTrials.gov ID
- NCT05820854
- Acronym / sponsor ID
- SCSE-OAC / 164/INT/2022
- Conditions
- Anticoagulants, Self Efficacy, Self Confidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 20 Apr 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.
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.
Detailed description
Oral anticoagulation therapy (OAC) is the most suitable treatment worldwide for the primary and secondary prevention of thromboembolism and stroke in patients with non-valvular atrial fibrillation (NVAF). However, the strategies to provide an optimal quality of anticoagulation control are still an open challenge for healthcare professionals. In this regard, understanding the health determinants underline the patient's adherence is fundamental in the research field to develop personalized patient-centered education interventions in clinical practice and consequently avoid low treatment adherence. Among these health determinants (e.g., patients' knowledge, health literacy, beliefs, etc), the patients' self-efficacy is underreported because a specific tool is not yet available to measure patients' self-efficacy regarding the health behaviors challenges in OAC self-care management.
The primary aim of this study is to develop the patients' self-care self-efficacy index in oral anticoagulation therapy management (SCSE-OAC) in adults with non-valvular atrial fibrillation and provide cross-cultural validity and reliability of the developed index measure.
More specifically, to assess the internal validity of the SCSE-OAC, content and construct validity proprieties will be tested for each translated version of the SECSE-OAC, as well as its reliability and invariance characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-valvular atrial fibrillation (NVAF) patients treated with oral anticoagulants | – | Other: Self-assess and reporting self-care self-efficacy levelsAdult outpatients (≥ 18 years) with NVAF and treated with OAC for at least three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Self-assess and reporting self-care self-efficacy levelsPatients will have to self-report the self-care self-efficacy levels they experienced in managing the OAC therapy. | Other | Non-valvular atrial fibrillation (NVAF) patients treated with oral anticoagulants |
Primary outcome
SCSE-OAC index
Time frame: data collection will perform at the first 1 day patient visit
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 39269742Magon 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.
- Derived from this study: PubMed 38267024Magon 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.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulants and Self Efficacy, run by IRCCS Policlinico S. Donato.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arianna Magon (3313812318, arianna.magon@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCSE-OAC index (time frame: data collection will perform at the first 1 day patient visit). 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 NCT05820854, which also lists 2 linked publications.
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 5 Oct 2023.