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Burden of Illness in Atrial Fibrillation

4. Februar 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Vorhofflimmern

Intervention / Behandlung

Arzneimittel: Standard of care in AF in Denmark

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

107532

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Dänemark
- - Many Locations, Dänemark

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte	Intervention / Behandlung
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	Arzneimittel: Standard of care in AF in Denmark As used in clinical practice, analysed as per drug class, not separate drugs.

Gruppe / Kohorte

Intervention / Behandlung

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

Arzneimittel: Standard of care in AF in Denmark

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+ Zeitfenster: 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+ Zeitfenster: 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+ Zeitfenster: 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+ Zeitfenster: 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 Zeitfenster: 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+ Zeitfenster: 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+ Zeitfenster: 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 Zeitfenster: up to 4 weeks		up to 4 weeks
Direct cost in AF (in total and per patient) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: up to 4 weeks		up to 4 weeks
Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population Zeitfenster: up to 4 weeks		up to 4 weeks
Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population Zeitfenster: up to 4 weeks		up to 4 weeks
Number of patients per average HAS-BLED-score in Danish AF-population Zeitfenster: up to 4 weeks		up to 4 weeks
Percentage (%) of patients per average HAS-BLED-score in Danish AF-population Zeitfenster: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA] Zeitfenster: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving warfarin Zeitfenster: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs] Zeitfenster: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving no treatment Zeitfenster: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA] Zeitfenster: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin Zeitfenster: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs] Zeitfenster: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: up to 4 weeks		up to 4 weeks
Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting Zeitfenster: 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 Zeitfenster: up to 4 weeks		up to 4 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bayer

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2015

Primärer Abschluss (Tatsächlich)

1. Dezember 2015

Studienabschluss (Tatsächlich)

1. Dezember 2015

Studienanmeldedaten

Zuerst eingereicht

7. Oktober 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. November 2015

Zuerst gepostet (Schätzen)

26. November 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

5. Februar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Februar 2016

Zuletzt verifiziert

1. Februar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

nicht-valvuläres Vorhofflimmern

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

18313

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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