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

Pulmonary Arterial Hypertension Clinical Trial

— Inventa  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468545
• Other study ID #: 15554
• Secondary ID: BAY-ILO-2010-01
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: August 28, 2014
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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. .

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The influence of educational training on Ventavis treatment compliance through the Insight system		12 months	No
Secondary	Number of events requiring non-planned visit or hospital admission related to PAH(Pulmonary Artery Hypertension), depending on the education sessions received.		12 months	No
Secondary	Number of events due to Inhaler-related errors		12 months	No
Secondary	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	No

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