Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH) (ETHAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038284
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : March 17, 2014
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension, Pulmonary Behavioral: Patient education Other: Data collection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension
Study Start Date : March 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Medication-related problems [ Time Frame: 18 months ]
    Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions

Secondary Outcome Measures :
  1. Patient Satisfaction with medication [ Time Frame: 18 months ]
    Comparison between the SATMED-Q(R) score at 18 months between the two groups

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038284

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
Sponsors and Collaborators
University Hospital, Grenoble
Study Director: Matthieu Roustit, PharmD Clinical Research Center - Inserm CIC03, Grenoble, France
Principal Investigator: Pison Christophe, MD, PhD University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble Identifier: NCT01038284     History of Changes
Other Study ID Numbers: DCIC 09 12
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by University Hospital, Grenoble:
Patient Education
Drug Toxicity

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases