Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System (Inventa)
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ClinicalTrials.gov Identifier: NCT01468545 |
Recruitment Status
:
Completed
First Posted
: November 9, 2011
Last Update Posted
: August 29, 2014
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Tracking Information | ||||
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First Submitted Date | November 7, 2011 | |||
First Posted Date | November 9, 2011 | |||
Last Update Posted Date | August 29, 2014 | |||
Study Start Date | October 2011 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
The influence of educational training on Ventavis treatment compliance through the Insight system [ Time Frame: 12 months ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01468545 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System | |||
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. | |||
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. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 50 PAH patients in treatment with Ventavis. | |||
Condition | Pulmonary Arterial Hypertension | |||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
38 | |||
Original Estimated Enrollment |
50 | |||
Actual Study Completion Date | June 2014 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01468545 | |||
Other Study ID Numbers | 15554 BAY-ILO-2010-01 ( Other Identifier: company internal ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor | Bayer | |||
Collaborators | Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain) | |||
Investigators |
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PRS Account | Bayer | |||
Verification Date | August 2014 |