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Burden of Illness in Atrial Fibrillation

4 februari 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

107532

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 90 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Läkemedel: Standard of care in AF in Denmark
As used in clinical practice, analysed as per drug class, not separate drugs.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bayer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2015

Primärt slutförande (Faktisk)

1 december 2015

Avslutad studie (Faktisk)

1 december 2015

Studieregistreringsdatum

Först inskickad

7 oktober 2015

Först inskickad som uppfyllde QC-kriterierna

25 november 2015

Första postat (Uppskatta)

26 november 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

5 februari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 februari 2016

Senast verifierad

1 februari 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18313

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