Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH) (ETHAP)
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Purpose
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.
This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.
The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.
| Condition | Intervention |
|---|---|
|
Hypertension, Pulmonary |
Behavioral: Patient education Other: Data collection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension |
- Medication-related problems [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions
- Patient Satisfaction with medication [ Time Frame: 18 months ] [ Designated as safety issue: No ]Comparison between the SATMED-Q(R) score at 18 months between the two groups
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: Control |
Other: Data collection
Clinical and biological data, treatment, medication errors and ADEs
|
| Active Comparator: Patient education |
Behavioral: Patient education
Pharmaceutical care of patients with PAH
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age over 18;
- Pulmonary arterial hypertension (NYHA II to IV);
- Any specific PAH treatment or oral anticoagulant.
Exclusion Criteria:
- Patients under 18 or protected by law;
- Patients who do not speak/understand French;
- Pregnancy;
- Patients enrolled in other clinical trials.
Contacts and Locations| France | |
| CHU Bordeaux | |
| Bordeaux, France | |
| CHU Brest | |
| Brest, France | |
| Hopital Antoine Beclere | |
| Clamart, France | |
| Clinical Research Center Inserm CIC03 - Grenoble University Hospital | |
| Grenoble, France, 38043 | |
| CHU Grenoble | |
| Grenoble, France | |
| CHU de Lille | |
| Lille, France | |
| CHU Nantes | |
| Nantes, France | |
| CHU de Nice | |
| Nice, France | |
| CHU Rouen | |
| Rouen, France | |
| CHU Strasbourg | |
| Strasbourg, France | |
| CHU Tours | |
| Tours, France | |
| Study Director: | Matthieu Roustit, PharmD | Clinical Research Center - Inserm CIC03, Grenoble, France |
| Principal Investigator: | Pison Christophe, MD, PhD | University Hospital, Grenoble |
More Information
No publications provided
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT01038284 History of Changes |
| Other Study ID Numbers: | DCIC 09 12 |
| Study First Received: | October 22, 2009 |
| Last Updated: | January 16, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Grenoble:
|
Patient Education Drug Toxicity |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013