check_circleStudy Completed

Pulmonary Arterial Hypertension

Bayer Identifier:

15554

ClinicalTrials.gov Identifier:

NCT01468545

EudraCT Number:

Not Available

EU CT Number:

Not Available
Educational training influence in patients with PAH(Pulmonary Artery Hypertension) on inhaled Ventavis treatment adherence evaluated trough INSIGHT system

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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. .

Trial summary

Enrollment Goal
38
Trial Dates
October 2011 - June 2014
Phase
N/A
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain

Primary Outcome

  • The influence of educational training on Ventavis treatment compliance through the Insight system
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of events requiring non-planned visit or hospital admission related to PAH(Pulmonary Artery Hypertension), depending on the education sessions received.
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of events due to Inhaler-related errors
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    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)
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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