check_circleStudy Completed
Pulmonary Arterial Hypertension
Bayer Identifier:
15554
ClinicalTrials.gov Identifier:
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.
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
BothAge
18 - N/ATrial summary
Enrollment Goal
38Trial Dates
October 2011 - June 2014Phase
N/ACould I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Spain |
Primary Outcome
- The influence of educational training on Ventavis treatment compliance through the Insight systemdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
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 monthsenhanced_encryptionNoSafety Issue:
- Number of events due to Inhaler-related errorsdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A