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| ID | Type | Description | Link |
|---|---|---|---|
| BAY-ILO-2010-01 | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Dra. Pilar Escribano SubÃas - Coordinator - HU 12 de Octubre - Madrid (Spain) | UNKNOWN |
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Ventavis it's a treatment for pulmonary hypertension, administered by an inhaler called I-Neb.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost (Ventavis inhaled, BAYQ6256) | Other | An extra educational reinforcement at baseline and at 6 months will be given to a group of patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| The influence of educational training on Ventavis treatment compliance through the Insight system | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of events requiring non-planned visit or hospital admission related to PAH(Pulmonary Artery Hypertension), depending on the education sessions received. | 12 months | |
| Number of events due to Inhaler-related errors | 12 months |
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Inclusion Criteria:
exclusion Criteria:
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50 PAH patients in treatment with Ventavis.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Spain |
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| Iloprost (Ventavis inhaled, BAYQ6256) | Other | No extra educational reinforcement. |
|
| The difference of adherence patient information (subjective data) through the Morisky-Green questionnaire and the one shown by the Insight registry (objective data) | 12 months |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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