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

Not Applicable

Completed

• Conditions: Patient Adherence; Patient Compliance
• Interventions: Behavioral: Control; Behavioral: Motivational interview

• Registration Number: NCT02941978
• Lead Sponsor: AHEPA University Hospital

Brief 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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Primary Completion: 2019-05
• Study Completion: 2019-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1140

Inclusion Criteria

1. Age over 18 years
2. 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.
3. 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

1. Patients unable to communicate via telephone for study interviewing
2. Patients with any medical disorder that would interfere with completion or evaluation of clinical study results
3. Patients that lived in assisted-care facilities or had terminal illness.
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subject Control	Control	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.
Subject on Motivational Interview	Motivational interview	1. 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. 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, aiming to improve adherence to OAC.

Primary Outcome Measures

Name	Time	Method
Adherence to OAC therapy	One year	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.

Secondary Outcome Measures

Name	Time	Method
OAC treatment gaps	One year	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	Three years	Clinical outcomes such as death, thromboembolic event, myocardial infraction or bleeding after hospitalization

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece