Pulmonary Arterial Hypertension
Conditions
Keywords
Education, Ventavis, Adherence, PAH, Pulmonary artery hypertension
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.
Interventions
An extra educational reinforcement at baseline and at 6 months will be given to a group of patients
Sponsors
Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
Bayer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The influence of educational training on Ventavis treatment compliance through the Insight system | 12 months |
Secondary
| 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 |
Countries
Spain
Outcome results
None listed