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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose:

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Hungary
      • Baja, Hungary
        • Boehringer Ingelheim Investigational Site 58
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 61
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 62
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 63
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 66
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 67
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 68
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 89
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site 90
      • Békéscsaba, Hungary
        • Boehringer Ingelheim Investigational Site 85
      • Cegléd, Hungary
        • Boehringer Ingelheim Investigational Site 55
      • Debrecen, Hungary
        • Boehringer Ingelheim Investigational Site 51
      • Dunakeszi, Hungary
        • Boehringer Ingelheim Investigational Site 64
      • Dunaújváros, Hungary
        • Boehringer Ingelheim Investigational Site 77
      • Edelény, Hungary
        • Boehringer Ingelheim Investigational Site 56
      • Esztergom, Hungary
        • Boehringer Ingelheim Investigational Site 78
      • Gyöngyös, Hungary
        • Boehringer Ingelheim Investigational Site 60
      • Hajdúnánás, Hungary
        • Boehringer Ingelheim Investigational Site 52
      • Kaposvár, Hungary
        • Boehringer Ingelheim Investigational Site 81
      • Kecskemét, Hungary
        • Boehringer Ingelheim Investigational Site 54
      • Kistokaj, Hungary
        • Boehringer Ingelheim Investigational Site 59
      • Komló, Hungary
        • Boehringer Ingelheim Investigational Site 74
      • Komárom, Hungary
        • Boehringer Ingelheim Investigational Site 71
      • Mosonmagyaróvár, Hungary
        • Boehringer Ingelheim Investigational Site 72
      • Mátraháza, Hungary
        • Boehringer Ingelheim Investigational Site 65
      • Nyírbátor, Hungary
        • Boehringer Ingelheim Investigational Site 83
      • Nyíregyháza, Hungary
        • Boehringer Ingelheim Investigational Site 53
      • Nyíregyháza, Hungary
        • Boehringer Ingelheim Investigational Site 88
      • Pécs, Hungary
        • Boehringer Ingelheim Investigational Site 73
      • Szeged, Hungary
        • Boehringer Ingelheim Investigational Site 87
      • Szentes, Hungary
        • Boehringer Ingelheim Investigational Site 84
      • Szigetszentmiklós, Hungary
        • Boehringer Ingelheim Investigational Site 69
      • Szombathely, Hungary
        • Boehringer Ingelheim Investigational Site 82
      • Tapolca, Hungary
        • Boehringer Ingelheim Investigational Site 76
      • Tatabánya, Hungary
        • Boehringer Ingelheim Investigational Site 79
      • Tiszaújváros, Hungary
        • Boehringer Ingelheim Investigational Site 57
      • Törökszentmiklós, Hungary
        • Boehringer Ingelheim Investigational Site 70
      • Várpalota, Hungary
        • Boehringer Ingelheim Investigational Site 75
      • Zalaegerszeg, Hungary
        • Boehringer Ingelheim Investigational Site 80
      • Érd, Hungary
        • Boehringer Ingelheim Investigational Site 86
  • Slovakia
      • Banská Bystrica, Slovakia
        • Boehringer Ingelheim Investigational Site 29
      • Bardejov, Slovakia
        • Boehringer Ingelheim Investigational Site 41
      • Bardejov, Slovakia
        • Boehringer Ingelheim Investigational Site 42
      • Bojnice, Slovakia
        • Boehringer Ingelheim Investigational Site 32
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 1
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 9
      • Cadca, Slovakia
        • Boehringer Ingelheim Investigational Site 45
      • Galanta, Slovakia
        • Boehringer Ingelheim Investigational Site 28
      • Gelnica, Slovakia
        • Boehringer Ingelheim Investigational Site 17
      • Hurbanovo, Slovakia
        • Boehringer Ingelheim Investigational Site 26
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 12
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 13
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 14
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 15
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 16
      • Levice, Slovakia
        • Boehringer Ingelheim Investigational Site 25
      • Lucenec, Slovakia
        • Boehringer Ingelheim Investigational Site 33
      • Lucenec, Slovakia
        • Boehringer Ingelheim Investigational Site 35
      • Lucenec, Slovakia
        • Boehringer Ingelheim Investigational Site 36
      • Martin, Slovakia
        • Boehringer Ingelheim Investigational Site 44
      • Michalovce, Slovakia
        • Boehringer Ingelheim Investigational Site 38
      • Myjava, Slovakia
        • Boehringer Ingelheim Investigational Site 4
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 22
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 23
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 24
      • Nová Bana, Slovakia
        • Boehringer Ingelheim Investigational Site 30
      • Nové Mesto n. Váhom, Slovakia
        • Boehringer Ingelheim Investigational Site 48
      • Nové Zámky, Slovakia
        • Boehringer Ingelheim Investigational Site 19
      • Nové Zámky, Slovakia
        • Boehringer Ingelheim Investigational Site 20
      • Nové Zámky, Slovakia
        • Boehringer Ingelheim Investigational Site 21
      • Piestany, Slovakia
        • Boehringer Ingelheim Investigational Site 5
      • Povazská Bystrica, Slovakia
        • Boehringer Ingelheim Investigational Site 47
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 39
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 40
      • Prievidza, Slovakia
        • Boehringer Ingelheim Investigational Site 31
      • Rimavská Sobota, Slovakia
        • Boehringer Ingelheim Investigational Site 11
      • Rimavská Sobota, Slovakia
        • Boehringer Ingelheim Investigational Site 34
      • Roznava, Slovakia
        • Boehringer Ingelheim Investigational Site 10
      • Senec, Slovakia
        • Boehringer Ingelheim Investigational Site 2
      • Senica, Slovakia
        • Boehringer Ingelheim Investigational Site 3
      • Spisská Nová Ves, Slovakia
        • Boehringer Ingelheim Investigational Site 18
      • Stropkov, Slovakia
        • Boehringer Ingelheim Investigational Site 37
      • Topolcany, Slovakia
        • Boehringer Ingelheim Investigational Site 27
      • Trnava, Slovakia
        • Boehringer Ingelheim Investigational Site 6
      • Trnava, Slovakia
        • Boehringer Ingelheim Investigational Site 7
      • Trnava, Slovakia
        • Boehringer Ingelheim Investigational Site 8
      • Trstená, Slovakia
        • Boehringer Ingelheim Investigational Site 46
      • Zilina, Slovakia
        • Boehringer Ingelheim Investigational Site 43
  • Slovenia
      • Golnik, Slovenia
        • Boehringer Ingelheim Investigational Site 49
      • Maribor-Pohorje, Slovenia
        • Boehringer Ingelheim Investigational Site 50

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with COPD
Procedure: Education
Education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Baseline and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
12 months and baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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