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Clinical Trials/NCT01038284
NCT01038284
Completed
Not Applicable

Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

University Hospital, Grenoble11 sites in 1 country101 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension, Pulmonary
Sponsor
University Hospital, Grenoble
Enrollment
101
Locations
11
Primary Endpoint
Medication-related problems
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Patient Satisfaction with medication(18 months)

Study Sites (11)

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