Improving Adherence and Clinical Outcomes of Cystic Fibrosis Patients Through a Collaborative Active Intervention Program of a Multidisciplinary Team
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To determine whether a collaborative intervention program of a multi disciplinary team improves adherence to routinely prescribed CF medications: Tobi, Pulmozyme, Colistine , HS, Creon and AquADEKs multivitamins.
研究概览
简要总结
The purpose of this study is to assess the impact of a collaborative active intervention program of a multi-disciplinary team on improving adherence to chronic medications and improve clinical outcomes in CF patients.
详细描述
Cystic fibrosis is a life-threatening hereditary multi-system disease predominantly affecting the pancreas and lungs. Advances in treatment have led to significant improvements in prognosis though this depends crucially upon adherence to treatment.
It has been demonstrated in chronic conditions that improving medication adherence can improve clinical outcome, though it can be a difficult and complex task.
This is the first trial assessing the impact of a collaborative active intervention program of a multi disciplinary team in improving adherence to specific chronic medications and improving clinical outcomes in CF patients.
The trial will be divided into two parts:
First Part The first part of the trial will be a retrospective one in which data will be collected at baseline, from eligible patient files and patients' pharmacy records receiving standard care for the past 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of Cystic fibrosis at all ages.
- •CF patients that should be treated with one or more of these chronic medications: Tobi (Tobramycin), Coliracin (Colistin), Pulmozyme (Dornase Alpha), Hypertonic Saline (HS), Creon (pancreatic enzymes), AquaADEKs (Multivitamin).
- •Patients willing to participate in a trial.
- •Presence of a parent/guardian capable of providing informed consent.
- •Patients attending CF clinic at least once every 12 months.
排除标准
- •Absence of a parent/guardian or unwillingness to provide permission.
- •Potential participant declines to provide assent.
- •Transplant patients.
结局指标
主要结局
To determine whether a collaborative intervention program of a multi disciplinary team improves adherence to routinely prescribed CF medications: Tobi, Pulmozyme, Colistine , HS, Creon and AquADEKs multivitamins.
时间窗: 6 months, 12 months
To determine whether a collaborative intervention program of a multi disciplinary team improves clinical outcomes such as: number of hospital admissions, number of IV ABx courses, and change in %FEV1, BMI.
时间窗: 6 months, 12 months
次要结局
- To inspect whether improved adherence to medications during intensive care for 1 year in CF will reduce cytokines and inflammatory markers(6 months, 12 months)
- To determine whether a collaborative intervention program of a multi-disciplinary team improves health related quality of life.(6 months, 12 months)
研究者
Prof. Ori Efrati
Head of Pediatric Pulmonary Dept
Sheba Medical Center