Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)

NCT ID: NCT01038284

Last Updated: 2014-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Hypertension, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type SHAM_COMPARATOR

Data collection

Intervention Type OTHER

Clinical and biological data, treatment, medication errors and ADEs

Patient education

Group Type ACTIVE_COMPARATOR

Patient education

Intervention Type BEHAVIORAL

Pharmaceutical care of patients with PAH

Interventions

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Patient education

Pharmaceutical care of patients with PAH

Intervention Type BEHAVIORAL

Data collection

Clinical and biological data, treatment, medication errors and ADEs

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu Roustit, PharmD

Role: STUDY_DIRECTOR

Clinical Research Center - Inserm CIC03, Grenoble, France

Pison Christophe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status

CHU Brest

Brest, , France

Site Status

Hopital Antoine Beclere

Clamart, , France

Site Status

Clinical Research Center Inserm CIC03 - Grenoble University Hospital

Grenoble, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CHU de Lille

Lille, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU de Nice

Nice, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32440738 (View on PubMed)

Other Identifiers

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DCIC 09 12

Identifier Type: -

Identifier Source: org_study_id

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