Patient NT-proBNP Values and Medication Adherence on Their GP's Screen to Guide Dose Adjustment in Heart Failure (LabAdhDoc)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Successful transmission
研究概览
简要总结
Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction. Laboratory measure the biomarker NT-proBNP (N-terminal pro-B type natriuretic peptide) to support clinical decision and to guide treatment at every stage of HF. Many patients (including HF patients) do not follow therapeutic recommendations. Electronic monitoring of medication intake gives precise information over time and is the gold standard to unveil inappropriate behaviour. Electronic Health Records (EHR) are repository of patient health data in digital format and are mostly locally configured in medical practices.
We aim to transmit laboratory results of NT-proBNP and estimates of medication adherence into the EHR system of primary care providers, with the objective to guide treatment and dose adjustment of multiple medications in patients with HF. Our project is *not* to develop a telemonitoring system.
详细描述
Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction. To support clinical decision and to guide treatment at every stage of HF, the measurement of the biomarker NT-proBNP (N-terminal pro-B type natriuretic peptide) has been recommended.
Many patients (including HF patients) do not follow therapeutic recommendations. Non-adherence to treatment can lead to acute decompensation that often requires urgent hospitalisation. Electronic monitoring of medication intake gives precise information over time and is the gold standard to unveil inappropriate behaviour. We developed Time4MedTM, a small device that records date and time of medication intake. The recorded electronic data are visualized in a scatter diagram and several adherence estimates can be calculated such as days with missed doses, taking adherence or timing adherence. Electronic Health Records (EHR) are repository of patient health data in digital format and are mostly locally configured in medical practices.
We aim to transmit laboratory results of NT-proBNP and estimates of medication adherence into the EHR system of primary care providers, with the objective to guide treatment and dose adjustment of multiple medications in patients with HF. Our project is *not* to develop a telemonitoring system.
This is a prospective, observational, feasibility study one medical practice in Basel-Stadt, one dedicated laboratory, and one community pharmacy as study centre.
Physicians will order NT-proBNP measurement and electronic adherence monitoring to patients with diagnosis New York Heart Association (NYHA) stage II-III, who are under guidelines-recommended multiple medications and whose clinical and/or biomedical targeted values are unmet (inadequate control). Laboratory and adherence reports will be generated in similar encrypted format and transferred via secured platform into physician's EHR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •is ≥ 18 years old;
- •was diagnosed with HF NYHA II-III;
- •is under multiple regimen (ACE-Inhibitors and/or mineralocorticoid receptor antagonist (MRA) and/or betablocker (BB) and/or diuretic and/or other);
- •did not reach targeted clinical and/or biomedical objectives (HF is inadequately controlled);
- •self-administers medication (no help or supervision from a third person);
- •is suspected of inappropriate intake behaviour;
- •accepts to use the monitoring device for one month;
- •accepts a home-visit from the study pharmacist one month later;
- •signs the informed consent form.
排除标准
- •Patients who are, in the opinion of the physician, unlikely to comply with the study schedule or are unsuitable for any other reason
结局指标
主要结局
Successful transmission
时间窗: one month
The adherence records transmitted by the pharmacy are available in the health records system of GPs
次要结局
- Physician satisfaction(through study completion, 1 year)