Clinical trial NCT01468545: Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Education
Ventavis
Adherence
PAH
Pulmonary artery hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
First posted: 2011-11-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 PAH patients in treatment with Ventavis.

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.


Eligibility criteria: 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. .

Primary outcomes:
measure: The influence of educational training on Ventavis treatment compliance through the Insight system
timeFrame: 12 months
Secondary outcomes:
measure: Number of events requiring non-planned visit or hospital admission related to PAH(Pulmonary Artery Hypertension), depending on the education sessions received.
timeFrame: 12 months
measure: Number of events due to Inhaler-related errors
timeFrame: 12 months
measure: The difference of adherence patient information (subjective data) through the Morisky-Green questionnaire and the one shown by the Insight registry (objective data)
timeFrame: 12 months
Other outcomes:
Locations:
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: