Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH) (ETHAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01038284
First received: October 22, 2009
Last updated: January 16, 2013
Last verified: January 2013

October 22, 2009
January 16, 2013
March 2010
December 2013   (final data collection date for primary outcome measure)
Medication-related problems [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions
  • Medication error [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Adverse drug events rate [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01038284 on ClinicalTrials.gov Archive Site
Patient Satisfaction with medication [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Comparison between the SATMED-Q(R) score at 18 months between the two groups
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Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Hypertension, Pulmonary
  • Behavioral: Patient education
    Pharmaceutical care of patients with PAH
  • Other: Data collection
    Clinical and biological data, treatment, medication errors and ADEs
  • Sham Comparator: Control
    Intervention: Other: Data collection
  • Active Comparator: Patient education
    Intervention: Behavioral: Patient education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01038284
DCIC 09 12
Yes
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Study Director: Matthieu Roustit, PharmD Clinical Research Center - Inserm CIC03, Grenoble, France
Principal Investigator: Pison Christophe, MD, PhD University Hospital, Grenoble
University Hospital, Grenoble
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP