Protocol of a clinical trial study involving educational intervention in patients treated with warfarin
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFMG |
Texto Completo: | http://hdl.handle.net/1843/47473 |
Resumo: | Background: Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. Oral anticoagulation is an effective strategy for primary and secondary prevention of stroke in patients with AF. Warfarin is an oral anticoagulant widely prescribed and, despite its benefits, the achievement of the goals of drug therapy depends on patient involvement, among other factors. Educational interventions can contribute for effectiveness and safety of oral anticoagulation therapy. We sought to describe the protocol of a clinical trial designed to evaluate the effect of a patient-centered educational strategy focused on low-income patients with AF and poor anticoagulation control. Methods: Patients ≥18 years with AF, on warfarin for at least 6 months and time in therapeutic range (TTR) <60% will be recruited at 2 anticoagulation clinics (ACs) in Brazil. Patients from 1 AC will be allocated to the intervention group and patients from the other AC will be allocated to the control group. Intervention group will attend educational sessions based on a patient-centered care approach, and the control group will receive usual care. The intervention will be based on Paulo Freire's theory and tailored according to practices involving health empowerment and techniques applied to individuals with limited socioeconomic status. The intervention is estimated to last 5 months. We will consider TTR as the primary outcome and knowledge and self-reported non-adherence to warfarin therapy as secondary outcomes. TTR values and non-adherence will be measured before intervention (T0) and at times immediately after (T1), and 3 (T2), 6 (T3), 9 (T4), and 12 (T5) months after intervention. Knowledge will be measured at times T0, T1 e T5. The calculated sample size indicated 85 patients in each group. Discussion: The proposed study aims to investigate whether an innovative educational approach to deliver care to a low-income population on warfarin improves anticoagulation control. Once our hypothesis is confirmed, our findings are expected to help improving anticoagulation control, knowledge on warfarin therapy and adherence to drug therapy. Thus, we believe our results may contribute to improve oral anticoagulation effectiveness in a low-income population. Trial registration: Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR- 9cy6py and UTN: U1111-1217-0151 (March, 2019). |
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2022-11-25T19:46:30Z2022-11-25T19:46:30Z20199822e1582910.1097/MD.00000000000158290025-7974http://hdl.handle.net/1843/47473Background: Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. Oral anticoagulation is an effective strategy for primary and secondary prevention of stroke in patients with AF. Warfarin is an oral anticoagulant widely prescribed and, despite its benefits, the achievement of the goals of drug therapy depends on patient involvement, among other factors. Educational interventions can contribute for effectiveness and safety of oral anticoagulation therapy. We sought to describe the protocol of a clinical trial designed to evaluate the effect of a patient-centered educational strategy focused on low-income patients with AF and poor anticoagulation control. Methods: Patients ≥18 years with AF, on warfarin for at least 6 months and time in therapeutic range (TTR) <60% will be recruited at 2 anticoagulation clinics (ACs) in Brazil. Patients from 1 AC will be allocated to the intervention group and patients from the other AC will be allocated to the control group. Intervention group will attend educational sessions based on a patient-centered care approach, and the control group will receive usual care. The intervention will be based on Paulo Freire's theory and tailored according to practices involving health empowerment and techniques applied to individuals with limited socioeconomic status. The intervention is estimated to last 5 months. We will consider TTR as the primary outcome and knowledge and self-reported non-adherence to warfarin therapy as secondary outcomes. TTR values and non-adherence will be measured before intervention (T0) and at times immediately after (T1), and 3 (T2), 6 (T3), 9 (T4), and 12 (T5) months after intervention. Knowledge will be measured at times T0, T1 e T5. The calculated sample size indicated 85 patients in each group. Discussion: The proposed study aims to investigate whether an innovative educational approach to deliver care to a low-income population on warfarin improves anticoagulation control. Once our hypothesis is confirmed, our findings are expected to help improving anticoagulation control, knowledge on warfarin therapy and adherence to drug therapy. Thus, we believe our results may contribute to improve oral anticoagulation effectiveness in a low-income population. Trial registration: Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR- 9cy6py and UTN: U1111-1217-0151 (March, 2019).Fundo: A fibrilação atrial (FA) é a arritmia sustentada mais comum em todo o mundo. A anticoagulação oral é uma estratégia eficaz para prevenção primária e secundária de AVC em pacientes com FA. A varfarina é um anticoagulante oral amplamente prescrito e, apesar de seus benefícios, o alcance dos objetivos da terapia medicamentosa depende do envolvimento do paciente, entre outros fatores. Intervenções educativas podem contribuir para a eficácia e segurança da terapia de anticoagulação oral. Procuramos descrever o protocolo de um ensaio clínico desenhado para avaliar o efeito de uma estratégia educacional centrada no paciente, focada em pacientes de baixa renda com FA e mau controle da anticoagulação. Métodos: Pacientes ≥18 anos com FA, em uso de varfarina por pelo menos 6 meses e tempo na faixa terapêutica (TTR) <60% serão recrutados em 2 clínicas de anticoagulação (ACs) no Brasil. Os pacientes de 1 AC serão alocados no grupo intervenção e os pacientes do outro AC serão alocados no grupo controle. O grupo de intervenção participará de sessões educativas com base na abordagem de cuidado centrado no paciente, e o grupo de controle receberá os cuidados usuais. A intervenção será baseada na teoria de Paulo Freire e adaptada de acordo com as práticas que envolvem o empoderamento em saúde e técnicas aplicadas a indivíduos com nível socioeconômico limitado. Estima-se que a intervenção dure 5 meses. Consideraremos a TTR como desfecho primário e o conhecimento e a não adesão autorrelatada à terapia com varfarina como desfechos secundários. Os valores de TTR e a não adesão serão medidos antes da intervenção (T0) e nos momentos imediatamente após (T1), e 3 (T2), 6 (T3), 9 (T4) e 12 (T5) meses após a intervenção. O conhecimento será medido nos tempos T0, T1 e T5. O tamanho amostral calculado indicou 85 pacientes em cada grupo. Discussão: O estudo proposto visa investigar se uma abordagem educacional inovadora para cuidar de uma população de baixa renda em uso de varfarina melhora o controle da anticoagulação. Uma vez confirmada nossa hipótese, espera-se que nossos achados ajudem a melhorar o controle da anticoagulação, o conhecimento sobre a terapia com varfarina e a adesão à terapia medicamentosa. Assim, acreditamos que nossos resultados podem contribuir para melhorar a eficácia da anticoagulação oral em uma população de baixa renda. Registro do ensaio: Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-9cy6py e UTN: U1111-1217-0151 (março de 2019).engUniversidade Federal de Minas GeraisUFMGBrasilENF - DEPARTAMENTO DE ENFERMAGEM APLICADAMedicineVarfarinaProtocolo de ensaio clínicoAnticoagulantesProtocol of a clinical trial study involving educational intervention in patients treated with warfarinProtocolo de um estudo de ensaio clínico envolvendo intervenção educacional em pacientes tratados com varfarinainfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://journals.lww.com/md-journal/Fulltext/2019/05310/Protocol_of_a_clinical_trial_study_involving.54.aspxMaria Auxiliadora Parreiras MartinsJosiane Moreira da CostaMilena Soriano MarcolinoHeloisa de Carvalho TorresRaissa Eda de ResendeHannah Cardoso BarbosaDaniel Dias Ribeiroapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGLICENSELicense.txtLicense.txttext/plain; charset=utf-82042https://repositorio.ufmg.br/bitstream/1843/47473/1/License.txtfa505098d172de0bc8864fc1287ffe22MD51ORIGINAL2019_Protocol of a clinical trial study involving.pdf2019_Protocol of a clinical trial study involving.pdfapplication/pdf820628https://repositorio.ufmg.br/bitstream/1843/47473/2/2019_Protocol%20of%20a%20clinical%20trial%20study%20involving.pdf8718f986dcfdeaaccb4b33028392c916MD521843/474732022-11-25 16:46:30.461oai:repositorio.ufmg.br:1843/47473TElDRU7vv71BIERFIERJU1RSSUJVSe+/ve+/vU8gTu+/vU8tRVhDTFVTSVZBIERPIFJFUE9TSVTvv71SSU8gSU5TVElUVUNJT05BTCBEQSBVRk1HCiAKCkNvbSBhIGFwcmVzZW50Ye+/ve+/vW8gZGVzdGEgbGljZW7vv71hLCB2b2Pvv70gKG8gYXV0b3IgKGVzKSBvdSBvIHRpdHVsYXIgZG9zIGRpcmVpdG9zIGRlIGF1dG9yKSBjb25jZWRlIGFvIFJlcG9zaXTvv71yaW8gSW5zdGl0dWNpb25hbCBkYSBVRk1HIChSSS1VRk1HKSBvIGRpcmVpdG8gbu+/vW8gZXhjbHVzaXZvIGUgaXJyZXZvZ++/vXZlbCBkZSByZXByb2R1emlyIGUvb3UgZGlzdHJpYnVpciBhIHN1YSBwdWJsaWNh77+977+9byAoaW5jbHVpbmRvIG8gcmVzdW1vKSBwb3IgdG9kbyBvIG11bmRvIG5vIGZvcm1hdG8gaW1wcmVzc28gZSBlbGV0cu+/vW5pY28gZSBlbSBxdWFscXVlciBtZWlvLCBpbmNsdWluZG8gb3MgZm9ybWF0b3Mg77+9dWRpbyBvdSB277+9ZGVvLgoKVm9j77+9IGRlY2xhcmEgcXVlIGNvbmhlY2UgYSBwb2zvv710aWNhIGRlIGNvcHlyaWdodCBkYSBlZGl0b3JhIGRvIHNldSBkb2N1bWVudG8gZSBxdWUgY29uaGVjZSBlIGFjZWl0YSBhcyBEaXJldHJpemVzIGRvIFJJLVVGTUcuCgpWb2Pvv70gY29uY29yZGEgcXVlIG8gUmVwb3NpdO+/vXJpbyBJbnN0aXR1Y2lvbmFsIGRhIFVGTUcgcG9kZSwgc2VtIGFsdGVyYXIgbyBjb250Ze+/vWRvLCB0cmFuc3BvciBhIHN1YSBwdWJsaWNh77+977+9byBwYXJhIHF1YWxxdWVyIG1laW8gb3UgZm9ybWF0byBwYXJhIGZpbnMgZGUgcHJlc2VydmHvv73vv71vLgoKVm9j77+9IHRhbWLvv71tIGNvbmNvcmRhIHF1ZSBvIFJlcG9zaXTvv71yaW8gSW5zdGl0dWNpb25hbCBkYSBVRk1HIHBvZGUgbWFudGVyIG1haXMgZGUgdW1hIGPvv71waWEgZGUgc3VhIHB1YmxpY2Hvv73vv71vIHBhcmEgZmlucyBkZSBzZWd1cmFu77+9YSwgYmFjay11cCBlIHByZXNlcnZh77+977+9by4KClZvY++/vSBkZWNsYXJhIHF1ZSBhIHN1YSBwdWJsaWNh77+977+9byDvv70gb3JpZ2luYWwgZSBxdWUgdm9j77+9IHRlbSBvIHBvZGVyIGRlIGNvbmNlZGVyIG9zIGRpcmVpdG9zIGNvbnRpZG9zIG5lc3RhIGxpY2Vu77+9YS4gVm9j77+9IHRhbWLvv71tIGRlY2xhcmEgcXVlIG8gZGVw77+9c2l0byBkZSBzdWEgcHVibGljYe+/ve+/vW8gbu+/vW8sIHF1ZSBzZWphIGRlIHNldSBjb25oZWNpbWVudG8sIGluZnJpbmdlIGRpcmVpdG9zIGF1dG9yYWlzIGRlIG5pbmd177+9bS4KCkNhc28gYSBzdWEgcHVibGljYe+/ve+/vW8gY29udGVuaGEgbWF0ZXJpYWwgcXVlIHZvY++/vSBu77+9byBwb3NzdWkgYSB0aXR1bGFyaWRhZGUgZG9zIGRpcmVpdG9zIGF1dG9yYWlzLCB2b2Pvv70gZGVjbGFyYSBxdWUgb2J0ZXZlIGEgcGVybWlzc++/vW8gaXJyZXN0cml0YSBkbyBkZXRlbnRvciBkb3MgZGlyZWl0b3MgYXV0b3JhaXMgcGFyYSBjb25jZWRlciBhbyBSZXBvc2l077+9cmlvIEluc3RpdHVjaW9uYWwgZGEgVUZNRyBvcyBkaXJlaXRvcyBhcHJlc2VudGFkb3MgbmVzdGEgbGljZW7vv71hLCBlIHF1ZSBlc3NlIG1hdGVyaWFsIGRlIHByb3ByaWVkYWRlIGRlIHRlcmNlaXJvcyBlc3Tvv70gY2xhcmFtZW50ZSBpZGVudGlmaWNhZG8gZSByZWNvbmhlY2lkbyBubyB0ZXh0byBvdSBubyBjb250Ze+/vWRvIGRhIHB1YmxpY2Hvv73vv71vIG9yYSBkZXBvc2l0YWRhLgoKQ0FTTyBBIFBVQkxJQ0Hvv73vv71PIE9SQSBERVBPU0lUQURBIFRFTkhBIFNJRE8gUkVTVUxUQURPIERFIFVNIFBBVFJPQ++/vU5JTyBPVSBBUE9JTyBERSBVTUEgQUfvv71OQ0lBIERFIEZPTUVOVE8gT1UgT1VUUk8gT1JHQU5JU01PLCBWT0Pvv70gREVDTEFSQSBRVUUgUkVTUEVJVE9VIFRPRE9TIEUgUVVBSVNRVUVSIERJUkVJVE9TIERFIFJFVklT77+9TyBDT01PIFRBTULvv71NIEFTIERFTUFJUyBPQlJJR0Hvv73vv71FUyBFWElHSURBUyBQT1IgQ09OVFJBVE8gT1UgQUNPUkRPLgoKTyBSZXBvc2l077+9cmlvIEluc3RpdHVjaW9uYWwgZGEgVUZNRyBzZSBjb21wcm9tZXRlIGEgaWRlbnRpZmljYXIgY2xhcmFtZW50ZSBvIHNldSBub21lKHMpIG91IG8ocykgbm9tZXMocykgZG8ocykgZGV0ZW50b3IoZXMpIGRvcyBkaXJlaXRvcyBhdXRvcmFpcyBkYSBwdWJsaWNh77+977+9bywgZSBu77+9byBmYXLvv70gcXVhbHF1ZXIgYWx0ZXJh77+977+9bywgYWzvv71tIGRhcXVlbGFzIGNvbmNlZGlkYXMgcG9yIGVzdGEgbGljZW7vv71hLgo=Repositório de PublicaçõesPUBhttps://repositorio.ufmg.br/oaiopendoar:2022-11-25T19:46:30Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false |
dc.title.pt_BR.fl_str_mv |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin |
dc.title.alternative.pt_BR.fl_str_mv |
Protocolo de um estudo de ensaio clínico envolvendo intervenção educacional em pacientes tratados com varfarina |
title |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin |
spellingShingle |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin Maria Auxiliadora Parreiras Martins Varfarina Protocolo de ensaio clínico Anticoagulantes |
title_short |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin |
title_full |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin |
title_fullStr |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin |
title_full_unstemmed |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin |
title_sort |
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin |
author |
Maria Auxiliadora Parreiras Martins |
author_facet |
Maria Auxiliadora Parreiras Martins Josiane Moreira da Costa Milena Soriano Marcolino Heloisa de Carvalho Torres Raissa Eda de Resende Hannah Cardoso Barbosa Daniel Dias Ribeiro |
author_role |
author |
author2 |
Josiane Moreira da Costa Milena Soriano Marcolino Heloisa de Carvalho Torres Raissa Eda de Resende Hannah Cardoso Barbosa Daniel Dias Ribeiro |
author2_role |
author author author author author author |
dc.contributor.author.fl_str_mv |
Maria Auxiliadora Parreiras Martins Josiane Moreira da Costa Milena Soriano Marcolino Heloisa de Carvalho Torres Raissa Eda de Resende Hannah Cardoso Barbosa Daniel Dias Ribeiro |
dc.subject.other.pt_BR.fl_str_mv |
Varfarina Protocolo de ensaio clínico Anticoagulantes |
topic |
Varfarina Protocolo de ensaio clínico Anticoagulantes |
description |
Background: Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. Oral anticoagulation is an effective strategy for primary and secondary prevention of stroke in patients with AF. Warfarin is an oral anticoagulant widely prescribed and, despite its benefits, the achievement of the goals of drug therapy depends on patient involvement, among other factors. Educational interventions can contribute for effectiveness and safety of oral anticoagulation therapy. We sought to describe the protocol of a clinical trial designed to evaluate the effect of a patient-centered educational strategy focused on low-income patients with AF and poor anticoagulation control. Methods: Patients ≥18 years with AF, on warfarin for at least 6 months and time in therapeutic range (TTR) <60% will be recruited at 2 anticoagulation clinics (ACs) in Brazil. Patients from 1 AC will be allocated to the intervention group and patients from the other AC will be allocated to the control group. Intervention group will attend educational sessions based on a patient-centered care approach, and the control group will receive usual care. The intervention will be based on Paulo Freire's theory and tailored according to practices involving health empowerment and techniques applied to individuals with limited socioeconomic status. The intervention is estimated to last 5 months. We will consider TTR as the primary outcome and knowledge and self-reported non-adherence to warfarin therapy as secondary outcomes. TTR values and non-adherence will be measured before intervention (T0) and at times immediately after (T1), and 3 (T2), 6 (T3), 9 (T4), and 12 (T5) months after intervention. Knowledge will be measured at times T0, T1 e T5. The calculated sample size indicated 85 patients in each group. Discussion: The proposed study aims to investigate whether an innovative educational approach to deliver care to a low-income population on warfarin improves anticoagulation control. Once our hypothesis is confirmed, our findings are expected to help improving anticoagulation control, knowledge on warfarin therapy and adherence to drug therapy. Thus, we believe our results may contribute to improve oral anticoagulation effectiveness in a low-income population. Trial registration: Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR- 9cy6py and UTN: U1111-1217-0151 (March, 2019). |
publishDate |
2019 |
dc.date.issued.fl_str_mv |
2019 |
dc.date.accessioned.fl_str_mv |
2022-11-25T19:46:30Z |
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2022-11-25T19:46:30Z |
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info:eu-repo/semantics/article |
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http://hdl.handle.net/1843/47473 |
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10.1097/MD.0000000000015829 |
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0025-7974 |
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eng |
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Medicine |
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Universidade Federal de Minas Gerais |
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Brasil |
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ENF - DEPARTAMENTO DE ENFERMAGEM APLICADA |
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Universidade Federal de Minas Gerais |
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