Patient Compliance Clinical Trial
— MISOAC-AFOfficial title:
Motivational Interviewing to Support Oral AntiCoagulation Adherence in Patients With Non-valvular Atrial Fibrillation (MISOAC-AF): A Prospective Randomized Clinical Study
NCT number | NCT02941978 |
Other study ID # | Card1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | August 2019 |
Verified date | November 2019 |
Source | AHEPA University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1140 |
Est. completion date | August 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Greece | AHEPA University Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
AHEPA University Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | One year | |
Secondary | Clinical Outcomes | Clinical outcomes such as death, thromboembolic event, myocardial infraction or bleeding after hospitalization | Three years |
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