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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01038284
First received: October 22, 2009
Last updated: March 14, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 101
Study Start Date: March 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038284

Locations
France
CHU Bordeaux
Bordeaux, France
CHU Brest
Brest, France
Hopital Antoine Beclere
Clamart, France
CHU Grenoble
Grenoble, France
Clinical Research Center Inserm CIC03 - Grenoble University Hospital
Grenoble, France, 38043
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
Investigators
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: March 14, 2014
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
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014