Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

Burden of Illness in Atrial Fibrillation

2016. február 4. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

107532

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Dánia
      • Many Locations, Dánia

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
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
Drog: Standard of care in AF in Denmark
As used in clinical practice, analysed as per drug class, not separate drugs.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

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

Másodlagos eredményintézkedések

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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Bayer

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2015. október 1.

Elsődleges befejezés (Tényleges)

2015. december 1.

A tanulmány befejezése (Tényleges)

2015. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2015. október 7.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2015. november 25.

Első közzététel (Becslés)

2015. november 26.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2016. február 5.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2016. február 4.

Utolsó ellenőrzés

2016. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 18313

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Iratkozz fel