Chronic Obstructive Pulmonary Disease (COPD) Outpatient on Demand Clinic

NCT00556816 | Completed DMC

• 1 other identifier: NL 14887.075.06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; outpatient on demand clinic

Outcome Measures

Primary Outcomes (1)

• change in health status (CCQ)

  2 years

Secondary Outcomes (3)

• use of medical care (visits to GP, ER, outpatient clinic)

  2 years

• quality of life (SGRQ and SF-36)

  2 years

• the number of appointments with the pulmonary nurse/ nurse practitioner

  2 years

Study Arms (2)

Conventional outpatient clinic

ACTIVE COMPARATOR

Conventional outpatient clinic

Behavioral: Control

On demand outpatient clinic

EXPERIMENTAL

On demand outpatient clinic

Behavioral: on demand clinic

Interventions

on demand clinic BEHAVIORAL

Outpatient on demand clinic

On demand outpatient clinic

Control BEHAVIORAL

conventional outpatient clinic

Conventional outpatient clinic

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients at least GOLD II (FEV1 \< 70%, FEV1/VC ratio \< 70%)
• age \> 40 years
• smoking history \> 10 pack years
• informed consent

You may not qualify if:

• significant or instable comorbidity
• a history of asthma
• drug or alcohol abuse
• incapacity to fill in questionnaires

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• L.N. Boom, Drs.

  Isala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

NL (1)