Skip to main content
Clinical Trials/NCT00556816
NCT00556816
Completed
Not Applicable

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

Isala1 site in 1 country100 target enrollmentSeptember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Isala
Enrollment
100
Locations
1
Primary Endpoint
change in health status (CCQ)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
October 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Isala
Responsible Party
Principal Investigator
Principal Investigator

Jan W.K. van den Berg

Dr.

Isala

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

change in health status (CCQ)

Time Frame: 2 years

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials