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| Sponsors and Collaborators: |
Isala Klinieken Dr. J van den Berg |
| Information provided by: | Isala Klinieken |
| ClinicalTrials.gov Identifier: | NCT00556816 |
Purpose
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.
| Condition | Intervention |
|
Chronic Obstructive Pulmonary Disease |
Behavioral: on demand clinic Behavioral: Control |
| MedlinePlus related topics: | COPD (Chronic Obstructive Pulmonary Disease) |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | COPD-C: COPD Outpatient on Demand Clinic. Study to Determine the Efficacy and Safety of on Demand Outpatient Clinics in COPD Patients |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2009 |
| Arms | Assigned Interventions |
|
B: Active Comparator
Conventional outpatient clinic
|
Behavioral: Control
conventional outpatient clinic
|
|
A: Experimental
On demand clinic
|
Behavioral: on demand clinic
Outpatient on demand clinic
|
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
Eligibility
| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: J.W.K. van den Berg, Dr. | +38-4242000 ext 4474 | j.w.k.van.den.berg@isala.nl |
| Netherlands | |||||
| Isala Klinieken | Recruiting | ||||
| Zwolle, Netherlands, 8011 JW | |||||
| Contact: J.W. van den Berg, Dr. 038-4242000 ext 4474 | |||||
| Principal Investigator: L.N. Boom | |||||
| Isala Klinieken |
| Dr. J van den Berg |
| Principal Investigator: | L.N. Boom, Drs. | Isala Klinieken |
More Information
| Responsible Party: | Isala klinieken ( Dr van den Berg ) |
| Study ID Numbers: | NL 14887.075.06 |
| First Received: | November 9, 2007 |
| Last Updated: | September 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00556816 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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