Improving Therapeutic Adherence of Adult Patients With Cystic Fibrosis: Impact of a Co-constructed Program by Patients and Health Caregivers.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Medication Adherence (coverage rate)
研究概览
简要总结
Background Cystic fibrosis is a life-threatening genetic disorder responsible for pulmonary failure and multi-systemic complications involving specific and large medical care burden. To date, no program has shown its effectiveness in improving therapeutic adherence. A new approach to develop a co-constructed program involving patients and professionals may contribute to improve therapeutic adherence.
Objectives The aim of the MUCOBS-Trial project is to create a program to increase therapeutic adherence and to evaluate its efficacy in adult patients with cystic fibrosis in 3 CF centers in France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Patients with Cystic Fibrosis
- •Aged 18 or more
- •Speaking / understanding French
- •Followed in one of the participating centers (CRCM of the Auvergne-Rhône-Alpes region)
- •Resident in Auvergne-Rhône-Alpes
- •Affiliated to the general health insurance scheme
排除标准
- •Transplanted Patients
- •Patients who participated in the working group for the co-construction of the intervention
结局指标
主要结局
Medication Adherence (coverage rate)
时间窗: 18 months.
Continuous multiple-interval measures of medication availability (CMA), including: * Medications for obstructive airway syndromes * Aerosolized bronchial fluidifier * Inhaled antibiotics * Vitamins * Hepatic and biliary therapeutics * Pancreatic enzyme replacement therapy * Medicinal products for acid disorders * Diabetes medications these measurements (coverage rate for each therapeutic class) will be aggregated to evaluate the medication adherence.
次要结局
- Clinical evolution : body mass index (BMI)(18 months)
- Adherence score evaluated by self-administered questionnaire(6 and 18 months)
- Cystic Fibrosis Knowledge Scale(6 and 18 months)
- Adherence to medications for obstructive airway syndromes(18 months.)
- Clinical evolution : Forced expiratory volume in 1 s as a percentage of predicted (%FEV1)(18 months)
- Adherence to physiotherapy(18 months)
- Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R)(6 and 18 months)