Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- CCQ-recovery time in the event of an exacerbation(Health status recovery time)
研究概览
简要总结
The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).
详细描述
Early detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this. The current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse visits and allocated to either usual care or an additional AP providing individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is our primary outcome. Additionally, healthcare utilisation, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline, 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio < 70%
- •age > 40 years
- •complaints of chronic cough
- •smoking history of more than 20 years or 15 pack-years
- •diagnosis of COPD as major functionally limiting disease and
- •current use of bronchodilator therapy.
排除标准
- •primary diagnosis of asthma
- •primary diagnosis of cardiac disease
- •presence of disease that could either effect mortality or participation in the study (e.g. confusional states).
结局指标
主要结局
CCQ-recovery time in the event of an exacerbation(Health status recovery time)
时间窗: 6-months
次要结局
- Symptom recovery time in the event of an exacerbation(6 months)
- Health Related Quality of Life - St George Respiratory Questionnaire(baseline and 6 months follow-up)
- The Hospital Anxiety and Depression Scale (HADS)(baseline and 6 months follow-up)
- Medical Research Council (MRC) Dyspnoea Scale(baseline and 6 months follow-up)
- Julius Self-Efficacy Scale(baseline and 6 months follow-up)
- Contact delay & treatment delay in the event of an exacerbation(6 months)
- Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)(6 months)
- Healthcare Utilization (The number of respiratory-related hospital admissions, hospital days, emergency room visits and scheduled and unscheduled visits or telephone calls to a RP and GP)(6 months)