Patient Compliance Clinical Trial
Official title:
Motivational Interviewing to Support Oral AntiCoagulation Adherence in Patients With Non-valvular Atrial Fibrillation (MISOAC-AF): A Prospective Randomized Clinical Study
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
1. 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.
2. 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.
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