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

This study has been completed.
Sponsor:
Collaborator:
Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01468545
First received: November 7, 2011
Last updated: August 28, 2014
Last verified: August 2014

November 7, 2011
August 28, 2014
October 2011
January 2013   (final data collection date for primary outcome measure)
The influence of educational training on Ventavis treatment compliance through the Insight system [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01468545 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Number of events due to Inhaler-related errors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

50 PAH patients in treatment with Ventavis.

Pulmonary Arterial Hypertension
  • 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 1
    Intervention: Other: Iloprost (Ventavis inhaled, BAYQ6256)
  • Group 2
    Intervention: Other: Iloprost (Ventavis inhaled, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
June 2014
January 2013   (final data collection date for primary outcome measure)

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. .
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01468545
15554, BAY-ILO-2010-01
No
Bayer
Bayer
Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
Study Director: Bayer Study Director Bayer
Bayer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP