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

NCT01388166 | Completed Results

• 1 other identifier: 205.483
• Study Type: observational
• Target: 1,253
• Locations: 2 countries
• Sites: 42

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From 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 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.

  Baseline and 6 months

Secondary Outcomes (2)

• 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

• Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline

  12 months and baseline

Study Arms (1)

Patients with COPD

Procedure: Education

Interventions

Education PROCEDURE

Education

Patients with COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD

You may qualify if:

• Male and female ambulatory outpatients being seen in a participating physicians office for routine care,
• Patients with a clinical diagnosis of COPD and already being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium (Spiriva® HandiHaler® or Respimat®) at least 1 month and within product label
• Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone

You may not qualify if:

• Uncooperative patients as judged by the physician
• Patients with any conditions excluded as per Country specific package insert
• Patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Pfizer: collaborator

Study Sites (90)

Boehringer Ingelheim Investigational Site 58

Baja, Hungary

Location

Boehringer Ingelheim Investigational Site 85

Békéscsaba, Hungary

Location

Boehringer Ingelheim Investigational Site 61

Budapest, Hungary

Location

Boehringer Ingelheim Investigational Site 62

Budapest, Hungary

Location

Boehringer Ingelheim Investigational Site 63

Budapest, Hungary

Location

Boehringer Ingelheim Investigational Site 66

Budapest, Hungary

Location

Boehringer Ingelheim Investigational Site 67

Budapest, Hungary

Location

Boehringer Ingelheim Investigational Site 68

Budapest, Hungary

Location

Boehringer Ingelheim Investigational Site 89

Budapest, Hungary

Location

Boehringer Ingelheim Investigational Site 90

Budapest, Hungary

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Boehringer Ingelheim Investigational Site 55

Cegléd, Hungary

Location

Boehringer Ingelheim Investigational Site 51

Debrecen, Hungary

Location

Boehringer Ingelheim Investigational Site 64

Dunakeszi, Hungary

Location

Boehringer Ingelheim Investigational Site 77

Dunaújváros, Hungary

Location

Boehringer Ingelheim Investigational Site 56

Edelény, Hungary

Location

Boehringer Ingelheim Investigational Site 78

Esztergom, Hungary

Location

Boehringer Ingelheim Investigational Site 86

Érd, Hungary

Location

Boehringer Ingelheim Investigational Site 60

Gyöngyös, Hungary

Location

Boehringer Ingelheim Investigational Site 52

Hajdúnánás, Hungary

Location

Boehringer Ingelheim Investigational Site 81

Kaposvár, Hungary

Location

Boehringer Ingelheim Investigational Site 54

Kecskemét, Hungary

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Boehringer Ingelheim Investigational Site 59

Kistokaj, Hungary

Location

Boehringer Ingelheim Investigational Site 71

Komárom, Hungary

Location

Boehringer Ingelheim Investigational Site 74

Komló, Hungary

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Boehringer Ingelheim Investigational Site 65

Mátraháza, Hungary

Location

Boehringer Ingelheim Investigational Site 72

Mosonmagyaróvár, Hungary

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Boehringer Ingelheim Investigational Site 83

Nyírbátor, Hungary

Location

Boehringer Ingelheim Investigational Site 53

Nyíregyháza, Hungary

Location

Boehringer Ingelheim Investigational Site 88

Nyíregyháza, Hungary

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Boehringer Ingelheim Investigational Site 73

Pécs, Hungary

Location

Boehringer Ingelheim Investigational Site 87

Szeged, Hungary

Location

Boehringer Ingelheim Investigational Site 84

Szentes, Hungary

Location

Boehringer Ingelheim Investigational Site 69

Szigetszentmiklós, Hungary

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Boehringer Ingelheim Investigational Site 82

Szombathely, Hungary

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Boehringer Ingelheim Investigational Site 76

Tapolca, Hungary

Location

Boehringer Ingelheim Investigational Site 79

Tatabánya, Hungary

Location

Boehringer Ingelheim Investigational Site 57

Tiszaújváros, Hungary

Location

Boehringer Ingelheim Investigational Site 70

Törökszentmiklós, Hungary

Location

Boehringer Ingelheim Investigational Site 75

Várpalota, Hungary

Location

Boehringer Ingelheim Investigational Site 80

Zalaegerszeg, Hungary

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Boehringer Ingelheim Investigational Site 29

Banská Bystrica, Slovakia

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Boehringer Ingelheim Investigational Site 41

Bardejov, Slovakia

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Boehringer Ingelheim Investigational Site 42

Bardejov, Slovakia

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Boehringer Ingelheim Investigational Site 32

Bojnice, Slovakia

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Boehringer Ingelheim Investigational Site 1

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 9

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 45

Čadca, Slovakia

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Boehringer Ingelheim Investigational Site 28

Galanta, Slovakia

Location

Boehringer Ingelheim Investigational Site 17

Gelnica, Slovakia

Location

Boehringer Ingelheim Investigational Site 26

Hurbanovo, Slovakia

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Boehringer Ingelheim Investigational Site 12

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 13

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 14

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 15

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 16

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 25

Levice, Slovakia

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Boehringer Ingelheim Investigational Site 33

Lučenec, Slovakia

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Boehringer Ingelheim Investigational Site 35

Lučenec, Slovakia

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Boehringer Ingelheim Investigational Site 36

Lučenec, Slovakia

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Boehringer Ingelheim Investigational Site 44

Martin, Slovakia

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Boehringer Ingelheim Investigational Site 38

Michalovce, Slovakia

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Boehringer Ingelheim Investigational Site 4

Myjava, Slovakia

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Boehringer Ingelheim Investigational Site 22

Nitra, Slovakia

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Boehringer Ingelheim Investigational Site 23

Nitra, Slovakia

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Boehringer Ingelheim Investigational Site 24

Nitra, Slovakia

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Boehringer Ingelheim Investigational Site 30

Nová Bana, Slovakia

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Boehringer Ingelheim Investigational Site 48

Nové Mesto N. Váhom, Slovakia

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Boehringer Ingelheim Investigational Site 19

Nové Zámky, Slovakia

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Boehringer Ingelheim Investigational Site 20

Nové Zámky, Slovakia

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Boehringer Ingelheim Investigational Site 21

Nové Zámky, Slovakia

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Boehringer Ingelheim Investigational Site 5

Piešťany, Slovakia

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Boehringer Ingelheim Investigational Site 47

Povazská Bystrica, Slovakia

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Boehringer Ingelheim Investigational Site 39

Prešov, Slovakia

Location

Boehringer Ingelheim Investigational Site 40

Prešov, Slovakia

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Boehringer Ingelheim Investigational Site 31

Prievidza, Slovakia

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Boehringer Ingelheim Investigational Site 11

Rimavská Sobota, Slovakia

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Boehringer Ingelheim Investigational Site 34

Rimavská Sobota, Slovakia

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Boehringer Ingelheim Investigational Site 10

Rožňava, Slovakia

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Boehringer Ingelheim Investigational Site 2

Senec, Slovakia

Location

Boehringer Ingelheim Investigational Site 3

Senica, Slovakia

Location

Boehringer Ingelheim Investigational Site 18

Spisská Nová Ves, Slovakia

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Boehringer Ingelheim Investigational Site 37

Stropkov, Slovakia

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Boehringer Ingelheim Investigational Site 27

Topoľčany, Slovakia

Location

Boehringer Ingelheim Investigational Site 6

Trnava, Slovakia

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Boehringer Ingelheim Investigational Site 7

Trnava, Slovakia

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Boehringer Ingelheim Investigational Site 8

Trnava, Slovakia

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Boehringer Ingelheim Investigational Site 46

Trstená, Slovakia

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Boehringer Ingelheim Investigational Site 43

Žilina, Slovakia

Location

Boehringer Ingelheim Investigational Site 49

Golnik, Slovenia

Location

Boehringer Ingelheim Investigational Site 50

Maribor-Pohorje, Slovenia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2014
• Results First Posted: December 4, 2014

Record last verified: 2014-11

Locations

SL (2); HU (40)