NCT02941978

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,140 (actual)
• Sponsor: AHEPA University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Patient Compliance
• Patient Adherence

Interventions

Type	Name	Description
BEHAVIORAL	Motivational interview	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
BEHAVIORAL	Control	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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-05-01
• Completion: 2019-08-01
• First posted: 2016-10-21
• Last updated: 2019-11-20

Locations

1 site across 1 country: Greece