Pulmonary Arterial HypertensionInventaNCT01468545
Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System
An observational study of Pulmonary Arterial Hypertension, run by Bayer at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Iloprost (Ventavis inhaled, BAYQ6256)
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 PAH patients in treatment with Ventavis.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
- Being tested
- Iloprost (Ventavis inhaled, BAYQ6256)
- Keywords
- Education, Ventavis, Adherence, PAH, Pulmonary artery hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost (Ventavis inhaled, BAYQ6256)Other
An extra educational reinforcement at baseline and at 6 months will be given to a group of patients
Iloprost (Ventavis inhaled, BAYQ6256)Other
No extra educational reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: Iloprost (Ventavis inhaled, BAYQ6256) | |
| Group 2 | Not described Receives: Other: Iloprost (Ventavis inhaled, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of educational training on Ventavis treatment compliance through the Insight system
Measured: 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.
Measured: 12 months
Number of events due to Inhaler-related errors
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468545
- Sponsor's protocol ID
- 15554
- Other IDs
- BAY-ILO-2010-01
- Acronym
- Inventa
- Status last verified
- Aug 2014
- First submitted
- 7 Nov 2011
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01468545
- Acronym / sponsor ID
- Inventa / 15554
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Education, Ventavis, Adherence, PAH, Pulmonary artery hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Iloprost (Ventavis inhaled, BAYQ6256) |
| Group 2 | – | Other: Iloprost (Ventavis inhaled, BAYQ6256) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 PAH patients in treatment with Ventavis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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. .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost (Ventavis inhaled, BAYQ6256)An extra educational reinforcement at baseline and at 6 months will be given to a group of patients | Other | Group 1 |
| Iloprost (Ventavis inhaled, BAYQ6256)No extra educational reinforcement. | Other | Group 2 |
Primary outcome
The influence of educational training on Ventavis treatment compliance through the Insight system
Time frame: 12 months
3 secondary outcomes
Number of events requiring non-planned visit or hospital admission related to PAH(Pulmonary Artery Hypertension), depending on the education sessions received.
Time frame: 12 months
Number of events due to Inhaler-related errors
Time frame: 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)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Bayer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of educational training on Ventavis treatment compliance through the Insight system (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.