Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)

Not Applicable

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Behavioral: Patient education; Other: Data collection

• Registration Number: NCT01038284
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-12-21
• Study First Posted: 2009-12-23
• Study Start: 2010-03
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient education	Patient education	-
Control	Data collection	-

Primary Outcome Measures

Name	Time	Method
Medication-related problems	18 months	Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction with medication	18 months	Comparison between the SATMED-Q(R) score at 18 months between the two groups

Trial Locations

Locations (11)

CHU de Lille; 🇫🇷 Lille, France

Hopital Antoine Beclere; 🇫🇷 Clamart, France

CHU de Nice; 🇫🇷 Nice, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU Brest; 🇫🇷 Brest, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Tours; 🇫🇷 Tours, France

Clinical Research Center Inserm CIC03 - Grenoble University Hospital; 🇫🇷 Grenoble, France