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ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Procedure: Education
Registration Number
NCT01388166
Lead Sponsor
Boehringer Ingelheim
Brief Summary

The objective of this observational study is to collect and evaluate data on medication adherence of patients on maintenance COPD therapy with long-acting anticholinergic (e.g. Spiriva® delivered by HandiHaler® or Respimat®) using the MMAS-8 questionnaire.

Detailed Description

Purpose:

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1253
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients with COPDEducation-
Primary Outcome Measures
NameTimeMethod
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From BaselineBaseline and 6 months

The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.

Secondary Outcome Measures
NameTimeMethod
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months.6 months and 12 months

The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence.

Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline12 months and baseline

The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence.

Trial Locations

Locations (90)

Boehringer Ingelheim Investigational Site 55

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Cegléd, Hungary

Boehringer Ingelheim Investigational Site 90

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 36

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Lucenec, Slovakia

Boehringer Ingelheim Investigational Site 35

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Lucenec, Slovakia

Boehringer Ingelheim Investigational Site 27

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Topolcany, Slovakia

Boehringer Ingelheim Investigational Site 2

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Senec, Slovakia

Boehringer Ingelheim Investigational Site 7

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Trnava, Slovakia

Boehringer Ingelheim Investigational Site 62

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 63

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 67

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 68

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 89

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 59

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Kistokaj, Hungary

Boehringer Ingelheim Investigational Site 74

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Komló, Hungary

Boehringer Ingelheim Investigational Site 72

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Mosonmagyaróvár, Hungary

Boehringer Ingelheim Investigational Site 53

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Nyíregyháza, Hungary

Boehringer Ingelheim Investigational Site 83

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Nyírbátor, Hungary

Boehringer Ingelheim Investigational Site 73

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Pécs, Hungary

Boehringer Ingelheim Investigational Site 87

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Szeged, Hungary

Boehringer Ingelheim Investigational Site 76

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Tapolca, Hungary

Boehringer Ingelheim Investigational Site 70

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Törökszentmiklós, Hungary

Boehringer Ingelheim Investigational Site 75

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Várpalota, Hungary

Boehringer Ingelheim Investigational Site 86

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Érd, Hungary

Boehringer Ingelheim Investigational Site 41

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Bardejov, Slovakia

Boehringer Ingelheim Investigational Site 42

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Bardejov, Slovakia

Boehringer Ingelheim Investigational Site 32

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Bojnice, Slovakia

Boehringer Ingelheim Investigational Site 1

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 9

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 26

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Hurbanovo, Slovakia

Boehringer Ingelheim Investigational Site 13

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 15

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 25

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Levice, Slovakia

Boehringer Ingelheim Investigational Site 64

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Dunakeszi, Hungary

Boehringer Ingelheim Investigational Site 78

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Esztergom, Hungary

Boehringer Ingelheim Investigational Site 65

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Mátraháza, Hungary

Boehringer Ingelheim Investigational Site 82

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Szombathely, Hungary

Boehringer Ingelheim Investigational Site 79

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Tatabánya, Hungary

Boehringer Ingelheim Investigational Site 66

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 77

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Dunaújváros, Hungary

Boehringer Ingelheim Investigational Site 52

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Hajdúnánás, Hungary

Boehringer Ingelheim Investigational Site 80

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Zalaegerszeg, Hungary

Boehringer Ingelheim Investigational Site 4

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Myjava, Slovakia

Boehringer Ingelheim Investigational Site 6

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Trnava, Slovakia

Boehringer Ingelheim Investigational Site 49

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Golnik, Slovenia

Boehringer Ingelheim Investigational Site 61

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Budapest, Hungary

Boehringer Ingelheim Investigational Site 58

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Baja, Hungary

Boehringer Ingelheim Investigational Site 71

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Komárom, Hungary

Boehringer Ingelheim Investigational Site 88

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Nyíregyháza, Hungary

Boehringer Ingelheim Investigational Site 69

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Szigetszentmiklós, Hungary

Boehringer Ingelheim Investigational Site 57

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Tiszaújváros, Hungary

Boehringer Ingelheim Investigational Site 29

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Banská Bystrica, Slovakia

Boehringer Ingelheim Investigational Site 17

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Gelnica, Slovakia

Boehringer Ingelheim Investigational Site 14

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 33

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Lucenec, Slovakia

Boehringer Ingelheim Investigational Site 23

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 47

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Povazská Bystrica, Slovakia

Boehringer Ingelheim Investigational Site 3

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Senica, Slovakia

Boehringer Ingelheim Investigational Site 37

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Stropkov, Slovakia

Boehringer Ingelheim Investigational Site 85

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Békéscsaba, Hungary

Boehringer Ingelheim Investigational Site 51

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Debrecen, Hungary

Boehringer Ingelheim Investigational Site 56

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Edelény, Hungary

Boehringer Ingelheim Investigational Site 60

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Gyöngyös, Hungary

Boehringer Ingelheim Investigational Site 84

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Szentes, Hungary

Boehringer Ingelheim Investigational Site 28

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Galanta, Slovakia

Boehringer Ingelheim Investigational Site 12

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 44

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Martin, Slovakia

Boehringer Ingelheim Investigational Site 31

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Prievidza, Slovakia

Boehringer Ingelheim Investigational Site 34

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Rimavská Sobota, Slovakia

Boehringer Ingelheim Investigational Site 10

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Roznava, Slovakia

Boehringer Ingelheim Investigational Site 43

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Zilina, Slovakia

Boehringer Ingelheim Investigational Site 81

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Kaposvár, Hungary

Boehringer Ingelheim Investigational Site 54

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Kecskemét, Hungary

Boehringer Ingelheim Investigational Site 16

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 38

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Michalovce, Slovakia

Boehringer Ingelheim Investigational Site 18

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Spisská Nová Ves, Slovakia

Boehringer Ingelheim Investigational Site 8

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Trnava, Slovakia

Boehringer Ingelheim Investigational Site 46

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Trstená, Slovakia

Boehringer Ingelheim Investigational Site 45

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Cadca, Slovakia

Boehringer Ingelheim Investigational Site 22

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 24

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 30

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Nová Bana, Slovakia

Boehringer Ingelheim Investigational Site 48

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Nové Mesto n. Váhom, Slovakia

Boehringer Ingelheim Investigational Site 19

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Nové Zámky, Slovakia

Boehringer Ingelheim Investigational Site 20

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Nové Zámky, Slovakia

Boehringer Ingelheim Investigational Site 21

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Nové Zámky, Slovakia

Boehringer Ingelheim Investigational Site 5

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Piestany, Slovakia

Boehringer Ingelheim Investigational Site 39

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Presov, Slovakia

Boehringer Ingelheim Investigational Site 40

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Presov, Slovakia

Boehringer Ingelheim Investigational Site 11

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Rimavská Sobota, Slovakia

Boehringer Ingelheim Investigational Site 50

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Maribor-Pohorje, Slovenia

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