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OpenTrials
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NCT Number: NCT01038284

Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient education

Behavioral

Pharmaceutical care of patients with PAH

Data Collection

Other

Clinical and biological data, treatment, medication errors and ADEs

Primary outcomes

  1. Medication-related problems

    Time frame: 18 months

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

Secondary outcomes

  1. Patient Satisfaction with medication

    Time frame: 18 months

    Comparison between the SATMED-Q(R) score at 18 months between the two groups

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

Acronym: ETHAP

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2009
Registry last updated
Mar 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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