Burden of Illness in Atrial Fibrillation
Burden of Illness in Atrial Fibrillation in Denmark
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Many Locations、デンマーク
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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 |
As used in clinical practice, analysed as per drug class, not separate drugs.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+
時間枠:up to 4 weeks
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up to 4 weeks
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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+
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
時間枠:up to 4 weeks
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up to 4 weeks
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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+
時間枠:up to 4 weeks
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up to 4 weeks
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Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
時間枠:up to 4 weeks
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up to 4 weeks
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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+
時間枠:up to 4 weeks
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up to 4 weeks
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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
時間枠:up to 4 weeks
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up to 4 weeks
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Direct cost in AF (in total and per patient)
時間枠:up to 4 weeks
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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
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Direct cost in AF-related stroke (in total and per patient)
時間枠:up to 4 weeks
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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
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Indirect cost in AF (in total and per patient)
時間枠:up to 4 weeks
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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
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Indirect cost in AF-related stroke (in total and per patient)
時間枠:up to 4 weeks
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
時間枠:up to 4 weeks
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CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)
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up to 4 weeks
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Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
時間枠:up to 4 weeks
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CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)
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up to 4 weeks
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Number of patients with AF-related stroke rated per average CHADS-score in Danish population
時間枠:up to 4 weeks
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up to 4 weeks
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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
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
時間枠:up to 4 weeks
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up to 4 weeks
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Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population
時間枠:up to 4 weeks
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up to 4 weeks
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Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients per average HAS-BLED-score in Danish AF-population
時間枠:up to 4 weeks
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up to 4 weeks
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Percentage (%) of patients per average HAS-BLED-score in Danish AF-population
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients in total and per CH2ADS2-VASc-score receiving warfarin
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
時間枠:up to 4 weeks
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up to 4 weeks
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Number of patients in total and per CH2ADS2-VASc-score receiving no treatment
時間枠:up to 4 weeks
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up to 4 weeks
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Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
時間枠:up to 4 weeks
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up to 4 weeks
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Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin
時間枠:up to 4 weeks
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up to 4 weeks
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Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
時間枠:up to 4 weeks
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up to 4 weeks
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Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment
時間枠:up to 4 weeks
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up to 4 weeks
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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
時間枠:up to 4 weeks
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up to 4 weeks
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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
時間枠:up to 4 weeks
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up to 4 weeks
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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
時間枠:up to 4 weeks
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up to 4 weeks
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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
時間枠:up to 4 weeks
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up to 4 weeks
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Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting
時間枠:up to 4 weeks
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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
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up to 4 weeks
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Direct and indirect cost of AC medication treatment patterns
時間枠:up to 4 weeks
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up to 4 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Standard of care in AF in Denmarkの臨床試験
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Compedica IncProfessional Education and Research Institute募集
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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University of PittsburghShadyside Hospital Foundation完了