The AIR Project - Advance Care Planning Individualised Approach and Research Project. A Single Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months
研究概览
简要总结
The study will investigate the effect of a palliative approach in the out-patient management of patients with COPD.
详细描述
Randomised control trial. A total of 90 patients will be randomise 1:1 to either palliative intervention or standard care.
The intervention group will receive follow up in a newly established outpatient clinic for COPD in the specialized palliative united and the control group will receive standard follow up in the respiratory out-patient clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •• Diagnosis of COPD by spirometry
- •Patients followed in Herlev and Gentofte hospitals' respiratory out-patient-clinics or admitted to Herlev or Gentofte hospital for acute exacerbation
- •2 or more admissions for acute exacerbation of COPD within the last 12 months
- •CAT > 20
- •Cognitive and linguistic able to understand and give informed consent
排除标准
- •• Expected remaining life time less than 6 months due to other disease than COPD e.g. active cancer
- •Participating in other studies
结局指标
主要结局
Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months
时间窗: baseline, 3 and 6 months
questionnaire measuring anxiety and Depression in 2 subscales in this study we use the total value of the 2 subscales combined. The higher the number the worse the psychological impact. HADS total was a range from 0 to 24 where 0 is no psychological distress
次要结局
- Change from Baseline EORTC QLQ-C15-PAL at 6 months(baseline, 3 and 6 months)
- Change from Baseline copd assessment test (CAT) at 6 months(baseline, 3 and 6 months)
- Change from Baseline Life-Space Assessment (LSA) at 6 months(baseline, 3 and 6 months)
研究者
Kristoffer Marsaa
Head of section, senior consultant MD
Herlev and Gentofte Hospital