NCT01038284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

3.9 years

First QC Date

October 22, 2009

Last Update Submit

March 14, 2014

Conditions

Hypertension, Pulmonary

Keywords

Patient EducationDrug Toxicity

Outcome Measures

Primary Outcomes (1)

  • Medication-related problems

    Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions

    18 months

Secondary Outcomes (1)

  • Patient Satisfaction with medication

    18 months

Study Arms (2)

Control

SHAM COMPARATOR
Other: Data collection

Patient education

ACTIVE COMPARATOR
Behavioral: Patient education

Interventions

Patient educationBEHAVIORAL

Pharmaceutical care of patients with PAH

Patient education
Data collectionOTHER

Clinical and biological data, treatment, medication errors and ADEs

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18;
  • Pulmonary arterial hypertension (NYHA II to IV);
  • Any specific PAH treatment or oral anticoagulant.

You may not qualify if:

  • Patients under 18 or protected by law;
  • Patients who do not speak/understand French;
  • Pregnancy;
  • Patients enrolled in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU Bordeaux

Bordeaux, France

Location

CHU Brest

Brest, France

Location

Hopital Antoine Beclere

Clamart, France

Location

Clinical Research Center Inserm CIC03 - Grenoble University Hospital

Grenoble, 38043, France

Location

CHU Grenoble

Grenoble, France

Location

CHU de Lille

Lille, France

Location

CHU Nantes

Nantes, France

Location

CHU de Nice

Nice, France

Location

CHU Rouen

Rouen, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Tours

Tours, France

Location

Related Publications (1)

  • 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.

    PMID: 32440738DERIVED

MeSH Terms

Conditions

Hypertension, PulmonaryDrug-Related Side Effects and Adverse Reactions

Interventions

Patient Education as TopicData Collection

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Matthieu Roustit, PharmD

    Clinical Research Center - Inserm CIC03, Grenoble, France

    STUDY DIRECTOR

  • Pison Christophe, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

December 23, 2009

Study Start

March 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

FR(11)