- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388166
ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice
November 28, 2014 updated by: Boehringer Ingelheim
ADESPI: Adherence to Spiriva® in Patients With COPD, Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice in Central & Eastern European Region
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Purpose:
Study Type
Observational
Enrollment (Actual)
1253
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baja, Hungary
- Boehringer Ingelheim Investigational Site 58
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Budapest, Hungary
- Boehringer Ingelheim Investigational Site 61
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Budapest, Hungary
- 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 66
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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 90
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Békéscsaba, Hungary
- Boehringer Ingelheim Investigational Site 85
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Cegléd, Hungary
- Boehringer Ingelheim Investigational Site 55
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Debrecen, Hungary
- Boehringer Ingelheim Investigational Site 51
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Dunakeszi, Hungary
- Boehringer Ingelheim Investigational Site 64
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Dunaújváros, Hungary
- Boehringer Ingelheim Investigational Site 77
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Edelény, Hungary
- Boehringer Ingelheim Investigational Site 56
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Esztergom, Hungary
- Boehringer Ingelheim Investigational Site 78
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Gyöngyös, Hungary
- Boehringer Ingelheim Investigational Site 60
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Hajdúnánás, Hungary
- Boehringer Ingelheim Investigational Site 52
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Kaposvár, Hungary
- Boehringer Ingelheim Investigational Site 81
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Kecskemét, Hungary
- Boehringer Ingelheim Investigational Site 54
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Kistokaj, Hungary
- Boehringer Ingelheim Investigational Site 59
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Komló, Hungary
- Boehringer Ingelheim Investigational Site 74
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Komárom, Hungary
- Boehringer Ingelheim Investigational Site 71
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Mosonmagyaróvár, Hungary
- Boehringer Ingelheim Investigational Site 72
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Mátraháza, Hungary
- Boehringer Ingelheim Investigational Site 65
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Nyírbátor, Hungary
- Boehringer Ingelheim Investigational Site 83
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Nyíregyháza, Hungary
- Boehringer Ingelheim Investigational Site 53
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Nyíregyháza, Hungary
- Boehringer Ingelheim Investigational Site 88
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Pécs, Hungary
- Boehringer Ingelheim Investigational Site 73
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Szeged, Hungary
- Boehringer Ingelheim Investigational Site 87
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Szentes, Hungary
- Boehringer Ingelheim Investigational Site 84
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Szigetszentmiklós, Hungary
- Boehringer Ingelheim Investigational Site 69
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Szombathely, Hungary
- Boehringer Ingelheim Investigational Site 82
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Tapolca, Hungary
- Boehringer Ingelheim Investigational Site 76
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Tatabánya, Hungary
- Boehringer Ingelheim Investigational Site 79
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Tiszaújváros, Hungary
- Boehringer Ingelheim Investigational Site 57
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Törökszentmiklós, Hungary
- Boehringer Ingelheim Investigational Site 70
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Várpalota, Hungary
- Boehringer Ingelheim Investigational Site 75
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Zalaegerszeg, Hungary
- Boehringer Ingelheim Investigational Site 80
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Érd, Hungary
- Boehringer Ingelheim Investigational Site 86
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Banská Bystrica, Slovakia
- Boehringer Ingelheim Investigational Site 29
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Bardejov, Slovakia
- Boehringer Ingelheim Investigational Site 41
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Bardejov, Slovakia
- Boehringer Ingelheim Investigational Site 42
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Bojnice, Slovakia
- Boehringer Ingelheim Investigational Site 32
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Bratislava, Slovakia
- Boehringer Ingelheim Investigational Site 1
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Bratislava, Slovakia
- Boehringer Ingelheim Investigational Site 9
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Cadca, Slovakia
- Boehringer Ingelheim Investigational Site 45
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Galanta, Slovakia
- Boehringer Ingelheim Investigational Site 28
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Gelnica, Slovakia
- Boehringer Ingelheim Investigational Site 17
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Hurbanovo, Slovakia
- Boehringer Ingelheim Investigational Site 26
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Kosice, Slovakia
- Boehringer Ingelheim Investigational Site 12
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Kosice, Slovakia
- Boehringer Ingelheim Investigational Site 13
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Kosice, Slovakia
- Boehringer Ingelheim Investigational Site 14
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Kosice, Slovakia
- Boehringer Ingelheim Investigational Site 15
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Kosice, Slovakia
- Boehringer Ingelheim Investigational Site 16
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Levice, Slovakia
- Boehringer Ingelheim Investigational Site 25
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Lucenec, Slovakia
- Boehringer Ingelheim Investigational Site 33
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Lucenec, Slovakia
- Boehringer Ingelheim Investigational Site 35
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Lucenec, Slovakia
- Boehringer Ingelheim Investigational Site 36
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Martin, Slovakia
- Boehringer Ingelheim Investigational Site 44
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Michalovce, Slovakia
- Boehringer Ingelheim Investigational Site 38
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Myjava, Slovakia
- Boehringer Ingelheim Investigational Site 4
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Nitra, Slovakia
- Boehringer Ingelheim Investigational Site 22
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Nitra, Slovakia
- Boehringer Ingelheim Investigational Site 23
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Nitra, Slovakia
- Boehringer Ingelheim Investigational Site 24
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Nová Bana, Slovakia
- Boehringer Ingelheim Investigational Site 30
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Nové Mesto n. Váhom, Slovakia
- Boehringer Ingelheim Investigational Site 48
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Nové Zámky, 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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Piestany, Slovakia
- Boehringer Ingelheim Investigational Site 5
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Povazská Bystrica, Slovakia
- Boehringer Ingelheim Investigational Site 47
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Presov, Slovakia
- Boehringer Ingelheim Investigational Site 39
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Presov, Slovakia
- Boehringer Ingelheim Investigational Site 40
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Prievidza, Slovakia
- Boehringer Ingelheim Investigational Site 31
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Rimavská Sobota, Slovakia
- Boehringer Ingelheim Investigational Site 11
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Rimavská Sobota, Slovakia
- Boehringer Ingelheim Investigational Site 34
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Roznava, Slovakia
- Boehringer Ingelheim Investigational Site 10
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Senec, Slovakia
- Boehringer Ingelheim Investigational Site 2
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Senica, Slovakia
- Boehringer Ingelheim Investigational Site 3
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Spisská Nová Ves, Slovakia
- Boehringer Ingelheim Investigational Site 18
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Stropkov, Slovakia
- Boehringer Ingelheim Investigational Site 37
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Topolcany, Slovakia
- Boehringer Ingelheim Investigational Site 27
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Trnava, Slovakia
- Boehringer Ingelheim Investigational Site 6
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Trnava, Slovakia
- Boehringer Ingelheim Investigational Site 7
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Trnava, Slovakia
- Boehringer Ingelheim Investigational Site 8
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Trstená, Slovakia
- Boehringer Ingelheim Investigational Site 46
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Zilina, Slovakia
- Boehringer Ingelheim Investigational Site 43
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Golnik, Slovenia
- Boehringer Ingelheim Investigational Site 49
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Maribor-Pohorje, Slovenia
- Boehringer Ingelheim Investigational Site 50
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
COPD
Description
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with COPD
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Education
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline
Time Frame: Baseline 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.
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Baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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.
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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
Time Frame: 12 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.
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12 months and baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 1, 2011
First Submitted That Met QC Criteria
July 4, 2011
First Posted (Estimate)
July 6, 2011
Study Record Updates
Last Update Posted (Estimate)
December 4, 2014
Last Update Submitted That Met QC Criteria
November 28, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 205.483
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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