I Change Adherence & Raise Expectations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 641
- 试验地点
- 36
- 主要终点
- Medication Adherence
研究概览
简要总结
The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement. Half the centers will receive the Comprehensive Adherence Program (CAP) for 2 years. CAP consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention). The other half of the centers will receive CAP in year 2 of the study. Participants are patients age 11-20 years old who are diagnosed with CF and have been prescribed at least one of the following medications for at least 6 months prior to signing the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung function decline rates, exacerbation rates, and patient reported measures including health related quality of life and CF knowledge and skills, as secondary outcomes.
A central goal of this study is to test the effectiveness of the comprehensive adherence program (CAP), described above, versus standard care (SC) for adolescents and young adults seen in outpatient CF clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients age 11 - 20 years old
- •Patients with a diagnosis of CF
- •Patients attend the accredited care center for regularly scheduled clinic visits
- •Patient must be prescribed at least one of the following medications for at least 6 months prior to signing the informed consent:
- •Azithromycin Hypertonic saline Pulmozyme® TOBI® Inhaled compounded tobramycin
- •Patient has consented to provide data to the CF Foundation Registry prior to conversion to PORTCFv2
排除标准
- •Patient is planning to change care teams within the next 2 years
- •Patient is seen at a satellite clinic
- •Patient is on the lung transplant list (Note: participation in this study will not delay or exclude patient from being placed on the transplant list in the future or receiving a transplant once enrolled in the study)
结局指标
主要结局
Medication Adherence
时间窗: 12 Months
Medication Possession Ratio (MPR) derived from pharmacy refill records
次要结局
- CF knowledge(24 Months)
- Skills associated with CF treatments(24 Months)
- Lung Function(24 Months)
- Health Related Quality of Life (HRQOL)(24 Months)
- Pulmonary exacerbation(24 months)
- CF hospitalizations(24 Months)