Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ven… (NCT01468545) | Clinical Trial Compass
CompletedNot Applicable
Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System
Spain38 participantsStarted 2011-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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. .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The influence of educational training on Ventavis treatment compliance through the Insight system