A Mobile Health Application to Improve Anticoagulation Care in Atrial Fibrillation: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Oral anticoagulant adherence
研究概览
简要总结
This study will assess the benefits of using a mobile health application designed for shared decision aid in anticoagulation therapy in patients with Atrial Fibrillation (AF). The aim is to improve their treatment adherence and time in therapeutic International Normalized Ratio (INR) range. The results of this study have the potential to lead to a sustainable and resource-efficient strategy for better prevent thromboembolic events in patients with atrial fibrillation.
详细描述
Atrial Fibrillation is a common disease, with important burden on morbidity and mortality and a challenging management. Its incidence and healthcare costs have increased over the decades. One of the most important features of this arrhythmia is its stroke risk, which can be reduced with the use of anticoagulants. Deciding about anticoagulation therapy is complicated due to frequent competing comorbidities and potential harms of the therapy itself. To achieve better outcomes in preventing stroke, it is paramount that decisions about atrial fibrillation treatment be shared between providers and patients.
Mobile health is empowering individuals to assume a more active role in monitoring and managing their chronic conditions and therapeutic regimens. Also, health professionals are being provided with fast and point-of-care information, which can facilitate decision-making.
Therefore, this study will investigate the effects of an mHealth application idealized to aid shared decision and improve anticoagulation care in atrial fibrillation.
Adults with atrial fibrillation will be recruited from anticoagulation outpatient clinics and Basic Health Units and randomized to either (1) an intervention group in which the mHealth application will be used during the consultations or (2) a control group receiving the usual care with anticoagulation.
It is hypothesized that the intervention group will achieve better anticoagulation outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >=18 years
- •Diagnostic of atrial fibrillation
- •Indication of oral anticoagulation by their physician, based on risk scores
- •Ability to speak, hear and understand Portuguese
- •Able to receive and read text messages through a cell phone
排除标准
- •Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension and not fluent in Portuguese.
结局指标
主要结局
Oral anticoagulant adherence
时间窗: 6 months
For patients on Non-vitamin K antagonists oral anticoagulants, a change from baseline in oral anticoagulant adherence at 6 months to achieve a percentage of days covered (PDC) from 50% to 80%.
Percent time in therapeutic INR (TTR)
时间窗: 6 months
For patients on Vitamin-K antagonists, a change from baseline in TTR at 6 months from 50% to 60%. TTR: percent time in therapeutic INR range calculated by Rosendaal method. An INR value of \>2.0 was defined as subtherapeutic, and an INR value \<3.0 was defined as supratherapeutic.
次要结局
- Decisional Conflict Scale(After decision about anticoagulant usually 30 minutes after consultation and on study completion (6 months))