Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Remotely Observed Therapy
研究概览
简要总结
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a systematic approach to linking treatment and feedback components to enhance adherence.
详细描述
Study Design: This will be a single group intervention involving a 28-day baseline (Phase 1), a 28-day treatment period with enhanced adherence feedback. Subjects will be treated with Cayston via a blue tooth enabled nebulizer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be 18 non-adherent CF patients
- •Stratified by age as adult supervised (8-12) adolescents (12-18) and young adults (19-30) and gender
- •Balanced for ethnicity and disease severity -Non-adherence status will be determined at screening based on an MAQ score <
排除标准
- •Inability to give informed consent or assent
结局指标
主要结局
Remotely Observed Therapy
时间窗: 140 days
Doses of medication as recorded by bluetooth device
次要结局
- Morisky Adherence Questionnaire(140 days)