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临床试验/NCT01038284
NCT01038284已完成不适用

Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

University Hospital, Grenoble12 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2010年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
12
主要终点
Medication-related problems

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Medication-related problems

时间窗: 18 months

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

次要结局

  • Patient Satisfaction with medication(18 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (12)

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