Chronic Obstructive Pulmonary Disease Clinical Trial
— COPD-COfficial title:
COPD-C: COPD Outpatient on Demand Clinic. Study to Determine the Efficacy and Safety of on Demand Outpatient Clinics in COPD Patients
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Netherlands | Isala Klinieken | Zwolle |
Lead Sponsor | Collaborator |
---|---|
Isala |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in health status (CCQ) | 2 years | No | |
Secondary | use of medical care (visits to GP, ER, outpatient clinic) | 2 years | Yes | |
Secondary | quality of life (SGRQ and SF-36) | 2 years | No | |
Secondary | the number of appointments with the pulmonary nurse/ nurse practitioner | 2 years | No |
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