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

November 18, 2019 updated by: Apostolos Tzikas, MD, PhD, AHEPA University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54637
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subject on 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.
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
Active Comparator: Subject 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to OAC therapy
Time Frame: 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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OAC treatment gaps
Time Frame: 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)
One year
Clinical Outcomes
Time Frame: Three years
Clinical outcomes such as death, thromboembolic event, myocardial infraction or bleeding after hospitalization
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Investigators

  • Principal Investigator: Apostolos Tzikas, MD, PhD, Ahepa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Card1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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