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The purpose of the study is to investigate the impact of motivational interviewing in the adherence of patients with AF to oral anticoagulation (OAC) regimens. Patients assigned to the intervention group will be interviewed and guided on the importance of adherence to OAC medication, and will be contacted at 1 week, 2 months, 6 months and 1 year after discharge for educational interactive sessions. Patients in the control group will receive usual treatment and will be contacted at 1 year after discharge.
Study Purpose: To investigate the impact of motivational interviewing in the adherence of patients with AF to oral anticoagulation (OAC) regimens
Trial Design: Prospective, two-arm, single-center, randomized controlled clinical trial
Sample Size: 1000 subjects
Population: Adults with Non-valvular Atrial Fibrillation (NVAF) hospitalized in the cardiology ward for any reason who receive OAC at hospital discharge.
Intervention
Control Patients assigned to the control group receive usual treatment, corresponding to standard practice and management of hospitalized patients with AF. Patients assigned to the control group will be contacted via telephone for a pre-specified interview at 1 year after discharge for outcome assessment.
Primary Outcome: The primary outcome is overall adherence to OAC in the year after hospitalization for any reason, reported as Proportion of Days Covered (PDC) by OAC regimens. Patients with a PDC >80% will be classified as adequately adherent.
Secondary Outcomes: The secondary outcomes include:
Clinical Duration:The total study duration (concerning the primary outcome) is expected to be 3-4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject on Motivational Interview | Experimental |
|
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| Subject Control | Active Comparator | Patients assigned to the control group will receive usual treatment and will be contacted via telephone for a pre-specified interview at 1 year after discharge for outcome assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interview | Behavioral | Patients assigned to the intervention group receive additional medical consultation aiming to boost optimal uptake of the anticoagulation regimen prescribed. Initially (i.e., at hospital discharge), this includes a physician-patient interactive session and provision of an educational leaflet. The leaflet is designed in a culturally and linguistically conceivable template in Greek language. It uses simple terms together with both written and pictorial materials. Patients in the intervention group will also undergo short telephonic sessions at 1 week, 2 months, 6 months and 12 months following hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to OAC therapy | The primary outcome is adherence to OAC therapy between the index date (date of hospital discharge) and the end of the 1-year follow-up period, assessed as Proportion of Days Covered (PDC) by OAC regimens. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| OAC treatment gaps | The percentage of patients who have i) continuous OAC use (no treatment gaps or gaps <7 days), ii) transient treatment gaps (7-89 days), and iii) major treatment gaps (3 months or more) | One year |
| Clinical Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
Anticoagulated patients on an intentionally short-term OAC prescription under physician's recommendations (i.e. lone recent AF episode) will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Apostolos Tzikas, MD, PhD | AHEPA University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital | Thessaloniki | 54637 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37311823 | Derived | Tsiartas E, Samaras A, Papazoglou AS, Kartas A, Moysidis DV, Gemousakakis E, Kamzolas O, Bekiaridou A, Doundoulakis I, Tzikas A, Giannakoulas G. Changes in CHA2DS2-VASc score and risk of ischemic stroke among patients with atrial fibrillation. Heart Vessels. 2023 Oct;38(10):1267-1276. doi: 10.1007/s00380-023-02278-1. Epub 2023 Jun 13. | |
| 35921643 |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
| Control | Behavioral | Patients assigned to the control group receive usual treatment, corresponding to standard practice and management of hospitalized patients with AF. For both patient-groups, the choice of OAC agent and any other background therapy is left to the discretion of the treating physician. |
|
Clinical outcomes such as death, thromboembolic event, myocardial infraction or bleeding after hospitalization
| Three years |
| Tsagkaris C, Papazoglou AS, Kartas A, Samaras A, Moysidis DV, Vouloagkas I, Baroutidou A, Bekiaridou A, Patsiou V, Chatzisolomou A, Panteris E, Karagiannidis E, Karvounis H, Tzikas A, Giannakoulas G. Polypharmacy and Major Adverse Events in Atrial Fibrillation. J Cardiovasc Pharmacol. 2022 Dec 1;80(6):826-831. doi: 10.1097/FJC.0000000000001339. |
| 35006026 | Derived | Baroutidou A, Kartas A, Samaras A, Papazoglou AS, Vrana E, Moysidis DV, Akrivos E, Papanastasiou A, Vouloagkas I, Botis M, Liampas E, Karagiannidis AG, Karagiannidis E, Efthimiadis G, Karvounis H, Tzikas A, Giannakoulas G. Associations of Atrial Fibrillation Patterns With Mortality and Cardiovascular Events: Implications of the MISOAC-AF Trial. J Cardiovasc Pharmacol Ther. 2022 Jan-Dec;27:10742484211069422. doi: 10.1177/10742484211069422. |
| 34580251 | Derived | Vrana E, Kartas A, Samaras A, Vasdeki D, Forozidou E, Liampas E, Karvounis H, Giannakoulas G, Tzikas A. Indications for percutaneous left atrial appendage occlusion in hospitalized patients with atrial fibrillation. J Cardiovasc Med (Hagerstown). 2022 Mar 1;23(3):176-182. doi: 10.2459/JCM.0000000000001226. |
| 32339234 | Derived | Tzikas A, Samaras A, Kartas A, Vasdeki D, Fotos G, Dividis G, Paschou E, Forozidou E, Tsoukra P, Kotsi E, Goulas I, Karvounis H, Giannakoulas G. Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomized clinical trial. Eur Heart J Cardiovasc Pharmacother. 2021 Apr 9;7(FI1):f63-f71. doi: 10.1093/ehjcvp/pvaa039. |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |