Clinical trial NCT02941978: Motivational Interviewing to Support Oral AntiCoagulation Adherence in Patients With Non-valvular Atrial Fibrillation (MISOAC-AF)
Official title: Motivational Interviewing to Support Oral AntiCoagulation Adherence in Patients With Non-valvular Atrial Fibrillation (MISOAC-AF): A Prospective Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Patient Adherence
Keywords: atrial fibrillation
oral anticoagulation
motivational intervention
adherence
treatment gaps
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 1140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to OAC therapy
timeFrame: One year
Secondary outcomes:
measure: OAC treatment gaps
timeFrame: One year
measure: Clinical Outcomes
timeFrame: Three years
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
Study officials:
affiliation: AHEPA University Hospital
name: Apostolos Tzikas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.