Clinical trial NCT01038284: Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)
Official title: Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: Patient Education
Drug Toxicity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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.

Primary outcomes:
measure: Medication-related problems
timeFrame: 18 months
Secondary outcomes:
measure: Patient Satisfaction with medication
timeFrame: 18 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHU Brest
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Grenoble
country: France
facility: Clinical Research Center Inserm CIC03 - Grenoble University Hospital
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHU de Lille
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU de Nice
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: Clinical Research Center - Inserm CIC03, Grenoble, France
name: Matthieu Roustit, PharmD
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble
name: Pison Christophe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21.