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

Tracking Information
First Submitted Date	November 7, 2011
First Posted Date	November 9, 2011
Last Update Posted Date	August 29, 2014
Study Start Date	October 2011
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 7, 2011)	The influence of educational training on Ventavis treatment compliance through the Insight system [ Time Frame: 12 months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01468545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 7, 2011)	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 ]; Number of events due to Inhaler-related errors [ Time Frame: 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) [ Time Frame: 12 months ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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.
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	50 PAH patients in treatment with Ventavis.
Condition	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; Other: Iloprost (Ventavis inhaled, BAYQ6256) No extra educational reinforcement.
Study Groups/Cohorts	Group 1 Intervention: Other: Iloprost (Ventavis inhaled, BAYQ6256); Group 2 Intervention: Other: Iloprost (Ventavis inhaled, BAYQ6256)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: August 28, 2014)	38
Original Estimated Enrollment; (submitted: November 7, 2011)	50
Actual Study Completion Date	June 2014
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
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. .
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Spain
Removed Location Countries
Administrative Information
NCT Number	NCT01468545
Other Study ID Numbers	15554; BAY-ILO-2010-01 ( Other Identifier: company internal )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor	Bayer
Collaborators	Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
Investigators	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	August 2014