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Burden of Illness in Atrial Fibrillation

4 februari 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Werkelijk)

107532

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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
Geneesmiddel: Standard of care in AF in Denmark
As used in clinical practice, analysed as per drug class, not separate drugs.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bayer

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2015

Primaire voltooiing (Werkelijk)

1 december 2015

Studie voltooiing (Werkelijk)

1 december 2015

Studieregistratiedata

Eerst ingediend

7 oktober 2015

Eerst ingediend dat voldeed aan de QC-criteria

25 november 2015

Eerst geplaatst (Schatting)

26 november 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

5 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

4 februari 2016

Laatst geverifieerd

1 februari 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 18313

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