Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF) : a randomized clinical trial
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissionsoup.com..
AIMS: We aimed to assess the impact of an educational, motivational intervention on the adherence to oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (AF).
METHODS AND RESULTS: Hospitalized patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing, and tailored counselling on medication adherence. The primary study outcome was adherence to OAC at 1 year, which was evaluated according to proportion of days covered (PDC) by OAC regimens and was assessed through nationwide registers of prescription claims. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, and clinical events. A total of 1009 patients were randomized, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group were adherent (PDC > 80%), compared with 55% (280/509) in the control group [adjusted odds ratio (aOR) 2.84, 95% confidence interval (CI) 2.14-3.75; P < 0.001]. Mean PDC ± standard deviation was 0.85 ± 0.26 and 0.75 ± 0.31, respectively (P < 0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year (aOR 2.42, 95% CI 1.71-3.41; P < 0.001). Usual medical care was associated with more major (≥3 months) treatment gaps (aOR 2.39, 95% CI 1.76-3.26; P < 0.001). Clinical events over a median follow-up period of 2 years did not differ among treatment groups.
CONCLUSION: In patients receiving OAC therapy for non-valvular AF, a multilevel motivational intervention significantly improved medication adherence and rate of therapy persistence, and reduced major gaps in treatment. No significant impact on clinical outcomes was observed.
TRIAL REGISTRATION NUMBER: NCT02941978.
| Errataetall: |
CommentIn: Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e14-e15. - PMID 32614414 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:7 |
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| Enthalten in: |
European heart journal. Cardiovascular pharmacotherapy - 7(2021), FI1 vom: 09. Apr., Seite f63-f71 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Tzikas, Apostolos [VerfasserIn] |
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| Links: |
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| Themen: |
Adherence |
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| Anmerkungen: |
Date Completed 30.03.2022 Date Revised 01.04.2022 published: Print ClinicalTrials.gov: NCT02941978 CommentIn: Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e14-e15. - PMID 32614414 Citation Status MEDLINE |
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| doi: |
10.1093/ehjcvp/pvaa039 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM30923297X |
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| 245 | 1 | 0 | |a Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF) |b a randomized clinical trial |
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| 500 | |a Date Revised 01.04.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02941978 | ||
| 500 | |a CommentIn: Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e14-e15. - PMID 32614414 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a AIMS: We aimed to assess the impact of an educational, motivational intervention on the adherence to oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (AF) | ||
| 520 | |a METHODS AND RESULTS: Hospitalized patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing, and tailored counselling on medication adherence. The primary study outcome was adherence to OAC at 1 year, which was evaluated according to proportion of days covered (PDC) by OAC regimens and was assessed through nationwide registers of prescription claims. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, and clinical events. A total of 1009 patients were randomized, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group were adherent (PDC > 80%), compared with 55% (280/509) in the control group [adjusted odds ratio (aOR) 2.84, 95% confidence interval (CI) 2.14-3.75; P < 0.001]. Mean PDC ± standard deviation was 0.85 ± 0.26 and 0.75 ± 0.31, respectively (P < 0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year (aOR 2.42, 95% CI 1.71-3.41; P < 0.001). Usual medical care was associated with more major (≥3 months) treatment gaps (aOR 2.39, 95% CI 1.76-3.26; P < 0.001). Clinical events over a median follow-up period of 2 years did not differ among treatment groups | ||
| 520 | |a CONCLUSION: In patients receiving OAC therapy for non-valvular AF, a multilevel motivational intervention significantly improved medication adherence and rate of therapy persistence, and reduced major gaps in treatment. No significant impact on clinical outcomes was observed | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT02941978 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Adherence | |
| 650 | 4 | |a Atrial fibrillation | |
| 650 | 4 | |a Motivational intervention | |
| 650 | 4 | |a Oral anticoagulation | |
| 650 | 4 | |a Treatment gaps | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
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| 700 | 1 | |a Kartas, Anastasios |e verfasserin |4 aut | |
| 700 | 1 | |a Vasdeki, Dimitra |e verfasserin |4 aut | |
| 700 | 1 | |a Fotos, George |e verfasserin |4 aut | |
| 700 | 1 | |a Dividis, George |e verfasserin |4 aut | |
| 700 | 1 | |a Paschou, Eleni |e verfasserin |4 aut | |
| 700 | 1 | |a Forozidou, Evropi |e verfasserin |4 aut | |
| 700 | 1 | |a Tsoukra, Paraskevi |e verfasserin |4 aut | |
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| 700 | 1 | |a Goulas, Ioannis |e verfasserin |4 aut | |
| 700 | 1 | |a Karvounis, Haralambos |e verfasserin |4 aut | |
| 700 | 1 | |a Giannakoulas, George |e verfasserin |4 aut | |
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