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Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)

Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01038284
Acronym
ETHAP
Enrollment
101
Registered
2009-12-23
Start date
2010-03-31
Completion date
2014-02-28
Last updated
2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

Keywords

Patient Education, Drug Toxicity

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.

Interventions

BEHAVIORALPatient education

Pharmaceutical care of patients with PAH

OTHERData collection

Clinical and biological data, treatment, medication errors and ADEs

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Medication-related problems18 monthsMedication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions

Secondary

MeasureTime frameDescription
Patient Satisfaction with medication18 monthsComparison between the SATMED-Q(R) score at 18 months between the two groups

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026