- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01038284
Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH) (ETHAP)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Clinical and biological data, treatment, medication errors and ADEs
|
ACTIVE_COMPARATOR: 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
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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