AIRDROP: Can we Improve Adherence to Inhaled Treatment for Pulmonary Arterial Hypertension?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire.
研究概览
简要总结
Pulmonary Arterial Hypertension is a rare and progressive condition that compromises pulmonary circulation and can lead to right ventricular failure. Despite recent advances in diagnosis and treatment, the median survival of patients is only 2.8 years. The treatment for this disease is based on drugs that act on three main pathways: prostacyclin, endothelin, and nitric oxide. Iloprost, a prostacyclin analogue available in an inhaled form, is an important and well-established treatment. However, its mandatory frequent administration, the need for a specific inhalation technique, and its adverse event profile make its use complex. Although pharmacotherapeutic and inhalation technique follow-up by a qualified professional is widely studied in diseases like asthma and COPD, its application in Pulmonary Arterial Hypertension still lacks evidence. Thus, this study aims to evaluate how a pharmacist's intervention can improve treatment adherence, mitigate side effects and difficulties associated with inhalation, in addition to optimizing clinical and hemodynamic outcomes in patients with Pulmonary Arterial Hypertension using iloprost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •"Adult patients aged ≥ 18 years, treated at the referral center for PH management at the Heart Institute of the University of São Paulo Medical School, with an invasive confirmed diagnosis of PAH (mean pulmonary arterial pressure [mPAP] greater than 20 mmHg at rest, pulmonary vascular resistance [PVR] equal to or greater than 2 Wood units, and pulmonary capillary wedge pressure [PCWP] equal to or less than 15 mmHg), and who have been using Iloprost.
排除标准
- •Patients who are unable to perform the 6-minute walk test (6MWT) or who have experienced gastrointestinal bleeding within the 12 weeks prior to the start of the study will be excluded.
研究组 & 干预措施
No healthcare professional intervention
No intervention
Healthcare professional intervention
The patients will receive guidance on inhaler use and adherence
干预措施: The patients will receive guidance on inhaler use and adherence (Device)
结局指标
主要结局
Medication Adherence Measured by the Martín-Bayarre-Grau (MBG) Questionnaire.
时间窗: over 20 weeks of follow-up
The impact of the pharmaceutical intervention on medication adherence will be measured by the Martín-Bayarre-Grau (MBG) Questionnaire, comparing scores before and after the study period.
次要结局
未报告次要终点
研究者
Caio Júlio César dos Santos Fernandes
Principal Investigator
University of Sao Paulo General Hospital
