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 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. Our aim is to
investigate whether this special type of outpatient clinical care is effective in the
management of COPD.
Study Type: Intervention
| Condition |
Intervention |
Phase |
Chronic Obstructive Pulmonary Disease
|
Array: Array
Array: Array
|
N/A
|
Study Design:Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Official Title: COPD-C: COPD Outpatient on Demand Clinic. Study to Determine the Efficacy and Safety of on Demand Outpatient Clinics in COPD Patients
Further Study Details:
Expected Total Enrollment:
Study Dates:September 2007 -
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
Ages Eligible for Study- Min: 40 Years Max: N/A
Gender: Both
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
Please refer to this study by ClinicalTrials.gov identifier: NCT00556816
Isala Klinieken - Zwolle, 8011 JW
J.W. van den Berg, Dr. 038-4242000
Record Last Reviewed:January 2009
Last Updated:January 27, 2009
Record First Recieved:November 9, 2007
ClinicalTrials.gov Identifier:NCT00556816
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 02, 2010