Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System (Inventa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468545
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : August 29, 2014
Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Other: Iloprost (Ventavis inhaled, BAYQ6256)

Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective, Non-interventional, Multi-centre Study. The Observation Period for Each Subject Covers 1 Year of Treatment. One Initial Visit and 4 Follow-up Visits Every 3 Months and One Extra Educational Reinforcement at Baseline and at 6 Months Will be Given to a Group of Patients.
Study Start Date : October 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2014

Group/Cohort Intervention/treatment
Group 1 Other: Iloprost (Ventavis inhaled, BAYQ6256)
An extra educational reinforcement at baseline and at 6 months will be given to a group of patients

Group 2 Other: Iloprost (Ventavis inhaled, BAYQ6256)
No extra educational reinforcement.

Primary Outcome Measures :
  1. The influence of educational training on Ventavis treatment compliance through the Insight system [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of events requiring non-planned visit or hospital admission related to PAH(Pulmonary Artery Hypertension), depending on the education sessions received. [ Time Frame: 12 months ]
  2. Number of events due to Inhaler-related errors [ Time Frame: 12 months ]
  3. The difference of adherence patient information (subjective data) through the Morisky-Green questionnaire and the one shown by the Insight registry (objective data) [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 PAH patients in treatment with Ventavis.

Inclusion Criteria:

  • Male or female patients > 18 years of age.
  • 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:

  • Patients with severe cognitive impairment.
  • 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. .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01468545

Many Locations, Spain
Sponsors and Collaborators
Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01468545     History of Changes
Other Study ID Numbers: 15554
BAY-ILO-2010-01 ( Other Identifier: company internal )
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by Bayer:
Pulmonary artery hypertension

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents