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Burden of Illness in Atrial Fibrillation

4 février 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Fibrillation auriculaire

Intervention / Traitement

Médicament: Standard of care in AF in Denmark

Type d'étude

Observationnel

Inscription (Réel)

107532

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Danemark
- - Many Locations, Danemark

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte	Intervention / Traitement
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	Médicament: Standard of care in AF in Denmark As used in clinical practice, analysed as per drug class, not separate drugs.

Groupe / Cohorte

Intervention / Traitement

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

Médicament: Standard of care in AF in Denmark

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+ Délai: 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+ Délai: 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+ Délai: 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+ Délai: 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 Délai: 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+ Délai: 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+ Délai: 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 Délai: up to 4 weeks		up to 4 weeks
Direct cost in AF (in total and per patient) Délai: 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) Délai: 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) Délai: 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) Délai: 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bayer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2015

Achèvement primaire (Réel)

1 décembre 2015

Achèvement de l'étude (Réel)

1 décembre 2015

Dates d'inscription aux études

Première soumission

7 octobre 2015

Première soumission répondant aux critères de contrôle qualité

25 novembre 2015

Première publication (Estimation)

26 novembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

5 février 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 février 2016

Dernière vérification

1 février 2016

Plus d'information

Termes liés à cette étude

Mots clés

Fibrillation auriculaire non valvulaire

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

18313

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Burden of Illness in Atrial Fibrillation