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
  Purpose

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.


Condition Intervention
Pulmonary Arterial Hypertension
Other: Iloprost (Ventavis inhaled, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The influence of educational training on Ventavis treatment compliance through the Insight system [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 38
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Group 2 Other: Iloprost (Ventavis inhaled, BAYQ6256)
No extra educational reinforcement.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

50 PAH patients in treatment with Ventavis.

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. .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468545

Locations
Spain
Many Locations, Spain
Sponsors and Collaborators
Bayer
Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01468545     History of Changes
Other Study ID Numbers: 15554, BAY-ILO-2010-01
Study First Received: November 7, 2011
Last Updated: August 28, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
Education
Ventavis
Adherence
PAH
Pulmonary artery hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014