Motivational Interviewing to Support Oral AntiCoagulation Adherence in Patients With Non-valvular Atrial Fibrillation (MISOAC-AF)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Motivational Interview - Baseline: At hospital discharge or one day before, patients assigned to the intervention group will be contacted in person by a study physician for an interactive session and will be given an educational leaflet. Both methods will aim to educate them about the risk for stroke and the importance of adherence to OAC medication, and motivate them to adhere to their OAC treatment plan. Motivational Interview - Follow-up: Patients assigned to the intervention group will be contacted via telephone for a pre-specified interview at 1 week, 2 months, 6 months and 1 year after discharge. The delegated study personnel will assess whether an intervention is required and provide specific support tailored to the needs of the patient, focusing on maintaining or improving patients' adherence to OAC 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: The rate of persistence: the proportion of patients who are on OAC after hospital discharge and continue receiving OAC at the end of the study period. 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) Clinical outcomes such as death, thromboembolic event, myocardial infraction or bleeding after hospitalization. Clinical Duration:The total study duration (concerning the primary outcome) is expected to be 3-4 years.

Official Title
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Motivational Interviewing to Support Oral AntiCoagulation Adherence in Patients With Non-valvular Atrial Fibrillation (MISOAC-AF): A Prospective Randomized Clinical Study

Conditions
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Patient Compliance, Patient Adherence

Intervention / Treatment
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* Behavioral: Motivational interview
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Patients with comorbid non-valvular AF, defined on the basis of physician-assigned diagnoses during the hospitalization or as previously documented in the medical record, and additionally documented on an electrocardiogram or 24-h Holter monitor, if available. Patients that receive OAC at hospital discharge or are eligible for OAC therapy (CHA2DS2-VASc score ≥1 for males and ≥2 for females). Exclusion Criteria: Patients unable to communicate via telephone for study interviewing Patients with any medical disorder that would interfere with completion or evaluation of clinical study results Patients that lived in assisted-care facilities or had terminal illness. Presence of metallic valves or moderate-to-severe mitral stenosis Anticoagulated patients on an intentionally short-term OAC prescription under physician's recommendations (i.e. lone recent AF episode) will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject on Motivational Interview<br>Motivational Interview - Baseline: At hospital discharge, patients assigned to the intervention group will be contacted in person by a study physician for an interactive session and will be given an educational leaflet. Both methods will aim to educate them about the risk for stroke and the importance of adherence to OAC medication. The leaflet will also provide some basic information on how to take OAC medication (doses, food interactions, skipping doses, etc.) and will describe the main clinical manifestations of side effects. Motivational Interview - Follow-up: Patients assigned to the intervention group will be contacted via telephone for a pre-specified interview at 1 week, 2 months, 6 months and 1 year after discharge. The delegated study personnel will assess whether an intervention is required and provide specific support tailored to the needs of the patient, aiming to improve adherence to OAC. | Behavioral: Motivational interview<br>* 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<br>|
| Active Comparator: Subject Control<br>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. | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Clinical outcomes such as death, thromboembolic event, myocardial infraction or bleeding after hospitalization | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, oral anticoagulation, motivational intervention, adherence, treatment gaps