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

NCT01468545 | Completed

• 2 other identifiers: 15554BAY-ILO-2010-01
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Education; Ventavis; Adherence; PAH; Pulmonary artery hypertension

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Group 1

Other: Iloprost (Ventavis inhaled, BAYQ6256)

Group 2

Other: Iloprost (Ventavis inhaled, BAYQ6256)

Interventions

Iloprost (Ventavis inhaled, BAYQ6256) OTHER

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 PAH patients in treatment with Ventavis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Many Locations, Spain

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

ES (1)