跳至主要内容
临床试验/NCT00556816
NCT00556816已完成不适用

COPD-C: COPD Outpatient on Demand Clinic. Study to Determine the Efficacy and Safety of on Demand Outpatient Clinics in COPD Patients

Isala2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Isala
入组人数
100
试验地点
2
主要终点
change in health status (CCQ)

研究概览

简要总结

COPD (chronic obstructive pulmonary disease) is a chronic disease which is increasing. Patients with COPD are the most important concern of the pulmonologists. At the outpatient clinic has been observed that the amount of new and regular COPD patients is of such a size that it seems to overwhelm the capacity of the outpatient clinic. Solutions could be substitution of medical care, longer intervals between the appointments or discharge from secondary medical care to primary care. The first point does not solve the lack of capacity, the second point is not allowed because it will decrease quality of care and transition of care is a temporary solution. COPD is a complex disease, whereby, and certainly in an advanced stadium, multidisciplinary and qualified expertise is needed.

The optimal control frequency of patients with COPD is unknown. COPD is a disease with fluctuating activity and complaints over time. There is a chance that patients are seen at a stable state at the regular outpatient clinical visits instead of moments when medical care is obligated. The regular management of the outpatient clinic will therefore result in an ineffective treatment of COPD patients. In this way general practitioners and even patients could suggest that visits to the outpatient pulmonary clinic are confounding less to a good treatment of COPD.

Outpatient clinical care on demand, initiated by patients in other chronic patient groups like rheumatoid arthritis and inflammatory bowel diseases, are proven to be safe and effective leading to less consumption and costs of medical care in comparison to standard outpatient clinical visits 2-5.

The outpatient clinical care on demand for COPD is not figured out yet. Our aim is to investigate whether this special type of outpatient clinical care is effective in the management of COPD.

详细描述

COPD (chronic obstructive pulmonary disease) is a chronic disease with an increasing prevalence in the next years. There has been calculated that between 1994 and 2015 COPD will increase for men and women with 43% and 142%. This will be caused by ageing of the population and the tendency towards more smoking women 1.

Patients with COPD are the most important concern of the pulmonologists. At the outpatient clinic, it has been observed that the amount of new and regular COPD patients is of such a size that it seems to overwhelm the capacity of the outpatient clinic. Solutions could be substitution of medical care (specialist replacement by nurse practitioner), longer intervals between the appointments, or discharge from secondary medical care to primary care. The first point doesn't solve the lack of capacity, the second point is not allowed because it will decrease quality of care, and transition of care is a temporary solution. COPD is a complex disease, whereby, and certainly in an advanced stadium, multidisciplinary and qualified expertise is needed.

The optimal control frequency of patients with COPD is unknown. COPD is a disease with fluctuating activity and complaints over time. There is a chance that patients are seen at a stable state at the regular outpatient clinical visits instead of moments when medical care is obligated. The regular management of the outpatient clinic will therefore result in an ineffective treatment of COPD patients. In this way, general practitioners and even patients could suggest that visits to the outpatient pulmonary clinic are confounding less to a good treatment of COPD.

Outpatient clinical care on demand, initiated by patients in other chronic patient groups like rheumatoid arthritis and inflammatory bowel diseases, are proven to be safe and effective leading to less consumption and costs of medical care in comparison to standard outpatient clinical visits 2-5.

The outpatient clinical care on demand for COPD is not figured out yet. The investigators' aim is to investigate whether this special type of outpatient clinical care is effective in the management of COPD

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD patients at least GOLD II (FEV1 < 70%, FEV1/VC ratio < 70%)
  • age > 40 years
  • smoking history > 10 pack years
  • informed consent

排除标准

  • significant or instable comorbidity
  • a history of asthma
  • drug or alcohol abuse
  • incapacity to fill in questionnaires

结局指标

主要结局

change in health status (CCQ)

时间窗: 2 years

次要结局

  • the number of appointments with the pulmonary nurse/ nurse practitioner(2 years)
  • use of medical care (visits to GP, ER, outpatient clinic)(2 years)
  • quality of life (SGRQ and SF-36)(2 years)

研究者

发起方
Isala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan W.K. van den Berg

Dr.

Isala

研究点 (2)

Loading locations...

相似试验