ArticleMedicine2019
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin.
Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical service organisation for adults with atrial fibrillation.The Cochrane database of systematic reviews · 2024Pooled it
- Assessing the knowledge of medical undergraduates on oral anticoagulation therapy.Journal of family medicine and primary care · 2023Article
- Construction and Validation of a Protocol Targeting Patients on Oral Anticoagulation with Warfarin.Arquivos brasileiros de cardiologia · 2023Article
- Implementation of a text messaging intervention to patients on warfarin therapy in Brazilian primary care units: a quasi-experimental study.BMC primary care · 2022Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAtrial 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.
methodsPatients ≥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 registrationRegistro Brasileiro de Ensaios Clínicos (ReBEC) RBR- 9cy6py and UTN: U1111-1217-0151 (March, 2019).
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