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

March 14, 2014 updated by: University Hospital, Grenoble

Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Chu Bordeaux
      • Brest, France
        • CHU Brest
      • Clamart, France
        • Hôpital Antoine Béclère
      • Grenoble, France
        • CHU Grenoble
      • Grenoble, France, 38043
        • Clinical Research Center Inserm CIC03 - Grenoble University Hospital
      • Lille, France
        • CHU de Lille
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • CHU de Nice
      • Rouen, France
        • CHU Rouen
      • Strasbourg, France
        • CHU Strasbourg
      • Tours, France
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction with medication
Time Frame: 18 months
Comparison between the SATMED-Q(R) score at 18 months between the two groups
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

December 21, 2009

First Posted (ESTIMATE)

December 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 09 12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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