COPD-C: Chronic Obstructive Pulmonary Disease (COPD) Outpatient on Demand Clinic

Sponsor
Isala (Other)
Overall Status
Completed
CT.gov ID
NCT00556816
Collaborator
(none)
100
1
2
49
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: on demand clinic
  • Behavioral: Control
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional outpatient clinic

Conventional outpatient clinic

Behavioral: Control
conventional outpatient clinic

Experimental: On demand outpatient clinic

On demand outpatient clinic

Behavioral: on demand clinic
Outpatient on demand clinic

Outcome Measures

Primary Outcome Measures

  1. change in health status (CCQ) [2 years]

Secondary Outcome Measures

  1. use of medical care (visits to GP, ER, outpatient clinic) [2 years]

  2. quality of life (SGRQ and SF-36) [2 years]

  3. the number of appointments with the pulmonary nurse/ nurse practitioner [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Isala Klinieken Zwolle Netherlands 8011 JW

Sponsors and Collaborators

  • Isala

Investigators

  • Principal Investigator: L.N. Boom, Drs., Isala

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan W.K. van den Berg, Dr., Isala
ClinicalTrials.gov Identifier:
NCT00556816
Other Study ID Numbers:
  • NL 14887.075.06
First Posted:
Nov 12, 2007
Last Update Posted:
Sep 18, 2015
Last Verified:
Sep 1, 2015
Keywords provided by Jan W.K. van den Berg, Dr., Isala
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2015