Building Adherence to Live With And Navigate my CF Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence.
研究概览
简要总结
The investigators research group and others have found that patient-reported adherence to all aspects of the regimen is suboptimal and objective measures suggest even poorer adherence. There is little data, however that identifies and examines the reason for nonadherence in an adult Cystic Fibrosis (CF) population or identifies effective strategies for improving adherence.
The investigators propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group). Specifically, The investigators hypothesize that MI will result in improved regimen adherence and reduced CF morbidity compared to the CFE control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a doctor confirmed diagnosis of CF
- •Age 16 years old or older
- •Prescribed an inhaled mucolytic, inhaled antibiotic therapy, chronic macrolide therapy and/or hypertonic saline therapy for the previous 12 months.
- •Scheduled for a regular visit at either the pediatric or the adult CF clinic at Johns Hopkins Hospital.
排除标准
- •Burkholderia cepacia complex isolated from the respiratory tract within the past 2 years.
- •Had a lung transplant
- •Participated in NA_00008649 A pilot study of Motivational Interviewing for adults with CF.
研究组 & 干预措施
Cystic Fibrosis Education
This intervention is designed to increase knowledge and enhance the skills needed to optimize CF-management. The strategies used to achieve improved adherence include providing didactic education and skills training, and proscriptively using behavioral modification strategies, such as positive reinforcement for desired behaviors, and problem-solving training to overcome barriers.
干预措施: Cystic Fibrosis Education (Other)
Motivational Interviewing
The Counselor's overarching goal for the intervention is to motivate and assist the participant to improve his/her adherence to the CF pulmonary medications. The intervention will begin by providing the patient personal feedback on their adherence (using pharmacy refill data) and health outcomes (e.g., trajectory of lung function values, frequency of exacerbations) as well as clinic-level figures showing the association between adherence and health outcomes.
干预措施: Motivational Interviewing (Behavioral)
结局指标
主要结局
A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence.
时间窗: 12 months
次要结局
- Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted.(12 months)
研究者
Kristin A. Riekert, PhD
Co-Director, The Johns Hopkins Adherence Research Center
Johns Hopkins University