Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01468545
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2011-11-07
Brief Title:
Educational Training Influence in Patients With PAHPulmonary Artery Hypertension on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System
Sponsor:
Bayer
Organization:
Bayer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Inventa
Brief Summary:
Ventavis its 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BAY-ILO-2010-01 | OTHER | company internal | None |