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Completed

NCT Number: NCT01468545

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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. .

Treatment and study plan

Iloprost (Ventavis inhaled, BAYQ6256)

Other

An extra educational reinforcement at baseline and at 6 months will be given to a group of patients

Primary outcomes

  1. The influence of educational training on Ventavis treatment compliance through the Insight system

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. Number of events due to Inhaler-related errors

    Time frame: 12 months

  3. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)

Registry information

Official study 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.

Acronym: Inventa

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 9, 2011
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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