Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT01038284
Last Updated: 2014-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2010-03-31
2014-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Control
Data collection
Clinical and biological data, treatment, medication errors and ADEs
Patient education
Patient education
Pharmaceutical care of patients with PAH
Interventions
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Patient education
Pharmaceutical care of patients with PAH
Data collection
Clinical and biological data, treatment, medication errors and ADEs
Eligibility Criteria
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Inclusion Criteria
* Pulmonary arterial hypertension (NYHA II to IV);
* Any specific PAH treatment or oral anticoagulant.
Exclusion Criteria
* Patients who do not speak/understand French;
* Pregnancy;
* Patients enrolled in other clinical trials.
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Matthieu Roustit, PharmD
Role: STUDY_DIRECTOR
Clinical Research Center - Inserm CIC03, Grenoble, France
Pison Christophe, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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CHU Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
Hopital Antoine Beclere
Clamart, , France
Clinical Research Center Inserm CIC03 - Grenoble University Hospital
Grenoble, , France
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
Countries
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References
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Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21.
Other Identifiers
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DCIC 09 12
Identifier Type: -
Identifier Source: org_study_id
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