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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Other: Iloprost (Ventavis inhaled, BAYQ6256); Other: Iloprost (Ventavis inhaled, BAYQ6256)

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Spain
  • Many Locations, Spain

Participation Criteria

Eligibility Criteria

• 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

50 PAH patients in treatment with Ventavis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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; Other: Iloprost (Ventavis inhaled, BAYQ6256); No extra educational reinforcement.
Group 2	Other: Iloprost (Ventavis inhaled, BAYQ6256); An extra educational reinforcement at baseline and at 6 months will be given to a group of patients; Other: Iloprost (Ventavis inhaled, BAYQ6256); No extra educational reinforcement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The influence of educational training on Ventavis treatment compliance through the Insight system	12 months

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (ESTIMATE): November 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Adherence; Education; PAH; Ventavis; Pulmonary artery hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 15554; BAY-ILO-2010-01 (OTHER: company internal)