Chronic Obstructive Pulmonary Disease (COPD) Outpatient on Demand Clinic (COPD-C)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
on demand clinic
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, outpatient on demand clinic
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
Sites / Locations
- Isala Klinieken
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional outpatient clinic
On demand outpatient clinic
Arm Description
Conventional outpatient clinic
On demand outpatient clinic
Outcomes
Primary Outcome Measures
change in health status (CCQ)
Secondary Outcome Measures
use of medical care (visits to GP, ER, outpatient clinic)
quality of life (SGRQ and SF-36)
the number of appointments with the pulmonary nurse/ nurse practitioner
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00556816
Brief Title
Chronic Obstructive Pulmonary Disease (COPD) Outpatient on Demand Clinic
Acronym
COPD-C
Official Title
COPD-C: COPD Outpatient on Demand Clinic. Study to Determine the Efficacy and Safety of on Demand Outpatient Clinics in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isala
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, outpatient on demand clinic
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional outpatient clinic
Arm Type
Active Comparator
Arm Description
Conventional outpatient clinic
Arm Title
On demand outpatient clinic
Arm Type
Experimental
Arm Description
On demand outpatient clinic
Intervention Type
Behavioral
Intervention Name(s)
on demand clinic
Intervention Description
Outpatient on demand clinic
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
conventional outpatient clinic
Primary Outcome Measure Information:
Title
change in health status (CCQ)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
use of medical care (visits to GP, ER, outpatient clinic)
Time Frame
2 years
Title
quality of life (SGRQ and SF-36)
Time Frame
2 years
Title
the number of appointments with the pulmonary nurse/ nurse practitioner
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L.N. Boom, Drs.
Organizational Affiliation
Isala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
12. IPD Sharing Statement
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Chronic Obstructive Pulmonary Disease (COPD) Outpatient on Demand Clinic
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