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Burden of Illness in Atrial Fibrillation

2016年2月4日更新者：Bayer

Burden of Illness in Atrial Fibrillation in Denmark

The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.

研究概览

地位

完全的

条件

心房颤动

干预/治疗

药品：Standard of care in AF in Denmark

研究类型

观察性的

注册 (实际的)

107532

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

丹麦
- - Many Locations、丹麦

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.

描述

Inclusion Criteria:

Primary and secondary diagnosis with AF;
The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.

Exclusion Criteria:

Patients younger than 18 and older than 90 years of age.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
AF patients in Denmark / Cohort 1 The base population of AF patients for diagnosis and health care utilization / resource use will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified. Further Data sources used: Registry of Medicinal Product Statistics: for determining the individuals' use of prescription medicine DREAM database: for investigation of sickness benefit and productivity loss Statistics Denmark's databases: on social services from municipalities Cause of Death Registry: AF-patients or controls who died during the study period (2000-2013) Danish Civil Registry: used for identification of controls, holds information about age, gender	药品：Standard of care in AF in Denmark As used in clinical practice, analysed as per drug class, not separate drugs.

团体/队列

干预/治疗

AF patients in Denmark / Cohort 1

The base population of AF patients for diagnosis and health care utilization / resource use will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.

Further Data sources used:

Registry of Medicinal Product Statistics: for determining the individuals' use of prescription medicine DREAM database: for investigation of sickness benefit and productivity loss Statistics Denmark's databases: on social services from municipalities Cause of Death Registry: AF-patients or controls who died during the study period (2000-2013) Danish Civil Registry: used for identification of controls, holds information about age, gender

药品：Standard of care in AF in Denmark

As used in clinical practice, analysed as per drug class, not separate drugs.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+ 大体时间：up to 4 weeks		up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+ 大体时间：up to 4 weeks		up to 4 weeks
Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+ 大体时间：up to 4 weeks		up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year and per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+ 大体时间：up to 4 weeks		up to 4 weeks
Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group 大体时间：up to 4 weeks		up to 4 weeks
Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+ 大体时间：up to 4 weeks		up to 4 weeks
Number of newly diagnosed patients with stroke in (non-valvular) AF-patients per year in Denmark by gender and age groups 18-65, 66-75, 75+, 80+ 大体时间：up to 4 weeks		up to 4 weeks
Mortality among stroke patients (in AF) compared with that of the population/the 'controls' and the total AF-population, if possible by gender and age group 大体时间：up to 4 weeks		up to 4 weeks
Direct cost in AF (in total and per patient) 大体时间：up to 4 weeks	Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks
Direct cost in AF-related stroke (in total and per patient) 大体时间：up to 4 weeks	Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks
Indirect cost in AF (in total and per patient) 大体时间：up to 4 weeks	Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks
Indirect cost in AF-related stroke (in total and per patient) 大体时间：up to 4 weeks	Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks

次要结果测量

结果测量	措施说明	大体时间
Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population 大体时间：up to 4 weeks	CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)	up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population 大体时间：up to 4 weeks	CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)	up to 4 weeks
Number of patients with AF-related stroke rated per average CHADS-score in Danish population 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish populationPercentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish population 大体时间：up to 4 weeks		up to 4 weeks
Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population 大体时间：up to 4 weeks		up to 4 weeks
Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population 大体时间：up to 4 weeks		up to 4 weeks
Number of patients per average HAS-BLED-score in Danish AF-population 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients per average HAS-BLED-score in Danish AF-population 大体时间：up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA] 大体时间：up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving warfarin 大体时间：up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs] 大体时间：up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving no treatment 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA] 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs] 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment 大体时间：up to 4 weeks		up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total 大体时间：up to 4 weeks		up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score 大体时间：up to 4 weeks		up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score 大体时间：up to 4 weeks		up to 4 weeks
Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting 大体时间：up to 4 weeks	Based on data from the National Patient Registry, the Primary Care Registry and the Registry of Medicinal Product Statistics and inclusion codes for specific fees/services, it will be possible to identify which patients are treated in an AC-clinic and which patients are treated in a GP-setting	up to 4 weeks
Direct and indirect cost of AC medication treatment patterns 大体时间：up to 4 weeks		up to 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bayer

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年10月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2015年10月7日

首先提交符合 QC 标准的

2015年11月25日

首次发布 (估计)

2015年11月26日

研究记录更新

最后更新发布 (估计)

2016年2月5日

上次提交的符合 QC 标准的更新

2016年2月4日

最后验证

2016年2月1日

Burden of Illness in Atrial Fibrillation