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

NCT02941978 | Completed

• 1 other identifier: Card1
• Study Type: interventional
• Target: 1,140
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Compliance; Patient Adherence

Keywords

atrial fibrillation; oral anticoagulation; motivational intervention; adherence; treatment gaps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• OAC treatment gaps

  One year

• Clinical Outcomes

  Three years

Study Arms (2)

Subject on Motivational Interview

EXPERIMENTAL

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

Subject Control

ACTIVE COMPARATOR

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

Interventions

Motivational interview BEHAVIORAL

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

Subject on Motivational Interview

Control BEHAVIORAL

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.

Subject Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54637, Greece

Location

Related Publications (5)

• Tsiartas E, Samaras A, Papazoglou AS, Kartas A, Moysidis DV, Gemousakakis E, Kamzolas O, Bekiaridou A, Doundoulakis I, Tzikas A, Giannakoulas G. Changes in CHA2DS2-VASc score and risk of ischemic stroke among patients with atrial fibrillation. Heart Vessels. 2023 Oct;38(10):1267-1276. doi: 10.1007/s00380-023-02278-1. Epub 2023 Jun 13.

  PMID: 37311823 DERIVED

• Tsagkaris C, Papazoglou AS, Kartas A, Samaras A, Moysidis DV, Vouloagkas I, Baroutidou A, Bekiaridou A, Patsiou V, Chatzisolomou A, Panteris E, Karagiannidis E, Karvounis H, Tzikas A, Giannakoulas G. Polypharmacy and Major Adverse Events in Atrial Fibrillation. J Cardiovasc Pharmacol. 2022 Dec 1;80(6):826-831. doi: 10.1097/FJC.0000000000001339.

  PMID: 35921643 DERIVED

• Baroutidou A, Kartas A, Samaras A, Papazoglou AS, Vrana E, Moysidis DV, Akrivos E, Papanastasiou A, Vouloagkas I, Botis M, Liampas E, Karagiannidis AG, Karagiannidis E, Efthimiadis G, Karvounis H, Tzikas A, Giannakoulas G. Associations of Atrial Fibrillation Patterns With Mortality and Cardiovascular Events: Implications of the MISOAC-AF Trial. J Cardiovasc Pharmacol Ther. 2022 Jan-Dec;27:10742484211069422. doi: 10.1177/10742484211069422.

  PMID: 35006026 DERIVED

• Vrana E, Kartas A, Samaras A, Vasdeki D, Forozidou E, Liampas E, Karvounis H, Giannakoulas G, Tzikas A. Indications for percutaneous left atrial appendage occlusion in hospitalized patients with atrial fibrillation. J Cardiovasc Med (Hagerstown). 2022 Mar 1;23(3):176-182. doi: 10.2459/JCM.0000000000001226.

  PMID: 34580251 DERIVED

• Tzikas A, Samaras A, Kartas A, Vasdeki D, Fotos G, Dividis G, Paschou E, Forozidou E, Tsoukra P, Kotsi E, Goulas I, Karvounis H, Giannakoulas G. Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomized clinical trial. Eur Heart J Cardiovasc Pharmacother. 2021 Apr 9;7(FI1):f63-f71. doi: 10.1093/ehjcvp/pvaa039.

  PMID: 32339234 DERIVED

MeSH Terms

Conditions

Patient Compliance; Atrial Fibrillation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Apostolos Tzikas, MD, PhD

  AHEPA University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: December 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

GR (1)