Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System
NCT ID: NCT01468545
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2011-10-31
2014-06-30
Brief Summary
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In these patients, the non compliance of the treatment becomes its ineffective and increases the complications and mortality of the disease.
It is therefore important to know which the adherence of patients to their treatment is and try to promote it.
One possibility to reach a good level of adherence is the patient education regarding the drug administration and also to comply as better is possible the recommendations of the physician.
For this reason, the objective of our study is to demonstrate improvement in the level of treatment compliance when they follow a strategy of continuing education, assessed by the device and software called Insight.
The only special procedure to participate in the study then is that patients involved could receive more training than usual.
Investigators expect involving in this study around 50 patients in treatment with Ventavis and diagnosed of Pulmonary Arterial Hypertension in 10-12 hospitals throughout Spain.
The patients who participated in the study will be followed for 12 months from inclusion in the study and will perform around 5 visits in total.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
Iloprost (Ventavis inhaled, BAYQ6256)
An extra educational reinforcement at baseline and at 6 months will be given to a group of patients
Group 2
Iloprost (Ventavis inhaled, BAYQ6256)
No extra educational reinforcement.
Interventions
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Iloprost (Ventavis inhaled, BAYQ6256)
An extra educational reinforcement at baseline and at 6 months will be given to a group of patients
Iloprost (Ventavis inhaled, BAYQ6256)
No extra educational reinforcement.
Eligibility Criteria
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Inclusion Criteria
* Patients in New York Heart Association (NYHA) functional class II-IV pulmonary hypertension who are treated with Ventavis at least three months before and who use -neb ® AAD ® system.
* Patients who accepted participation in the study and sign informed consent.
* Patients with ability to understand and follow the instructions and are able to participate for the duration of the study.
Exclusion Criteria
* Geographically unstable patients who can not be followed during the 12 month study.
* Patients who have a life expectancy of at least 12 months.
* Patients who are participating in another study at the time of inclusion. .
18 Years
ALL
No
Sponsors
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Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
UNKNOWN
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Many Locations, , Spain
Countries
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Other Identifiers
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BAY-ILO-2010-01
Identifier Type: OTHER
Identifier Source: secondary_id
15554
Identifier Type: -
Identifier Source: org_study_id