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(Cost-)Effectiveness Interdisciplinary Community-Based COPD Management Program (INTERCOM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00840892
First Posted: February 11, 2009
Last Update Posted: February 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Maxima Medical Center
Erasmus Medical Center
The Netherlands Asthma Foundation
Stichting Astma Bestrijding, The Netherlands
Nutricia Netherlands
PICASSO: Partners in Care Solutions for COPD
Information provided by:
Maastricht University Medical Center
  Purpose

There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung function, skeletal muscle weakness and weight loss are important determinants of impaired exercise performance, decreased quality of life and increased mortality. Based on earlier succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre developed an integrated, inter-disciplinary approach to the management of COPD including physical exercise, nutritional therapy, education, smoking cessation and psychological consultation. This COPD management program consists of a set of protocols that cover patient recruitment, diagnostic testing, treatment, follow-up and communication between professionals.

The exercise program and the nutitional therapy are carried out by local physiotherapists and dieticians working outside but in conjunction with the hospital. A program in such a setting could be substantially less expensive and certainly more easily accessible for many more patients than an inpatient or hospital-based outpatient rehabilitation program, as it is offered close to a patient's home. This study investigates the (cost-)effectiveness of the COPD management program compared to usual care in a randomized controlled trial.

Patients with moderate to severe COPD and a reduced exercise capacity during an incremental exercise test of less than 70% of predicted, are randomised to a treatment or a control group. The treatment group will participate in the COPD management program during the first 4 months after which they will be followed up for the remaining months. Both groups (n=100) are followed for 2 years and outcomes will be assessed at the beginning of the program, after 4, 12 and 24 months by disease-specific and generic measures of health status, body composition, skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility analysis with a two-year time horizon will be performed. The analysis is conducted from a societal perspectice, including the program costs and all COPD-related direct costs within and outside the healthcare sector ans costs of lost productivity.


Condition Intervention
Pulmonary Disease, Chronic Obstructive Other: INTERdisciplinary COMmunity-based COPD management (INTERCOM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-Based COPD Management Program Relative to Usual Care.

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations

Secondary Outcome Measures:
  • dyspnea, quality of life, exercise performance measures, body composition measures and lung function

Enrollment: 199
Study Start Date: January 2002
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: Intercom
INTERdisciplinary COMmunity-based COPD management (INTERCOM)
Other: INTERdisciplinary COMmunity-based COPD management (INTERCOM)
The INTERCOM program consisted of exercise training, education, nutritional therapy and smoking cessation support offered by local physiotherapists and dieticians in the proximity of the patient's home and by respiratory nurses in the hospital. The program was divided in a 4-month intensive intervention phase, followed by a 20-month maintenance phase.
No Intervention: Usual Care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe COPD according to the recent GOLD guidelines
  • Reduced exercise capacity during an incremental exercise test of less than 70% of predicted normal values

Exclusion Criteria:

  • Lack of motivation to participate in the treatment program
  • Other pathologic conditions unabling participation in the training program (e.g. coronary, orthopaedic, neurological or severe endocrine disorders)
  • participation in other pulmonary rehabilitation projects
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840892


Locations
Netherlands
Catharina Hospital
Eindhoven, Netherlands
Maxima Medical Centre
Veldhoven/Eindhoven, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Maxima Medical Center
Erasmus Medical Center
The Netherlands Asthma Foundation
Stichting Astma Bestrijding, The Netherlands
Nutricia Netherlands
PICASSO: Partners in Care Solutions for COPD
Investigators
Principal Investigator: Annemie MWJ Schols, Prof PhD Maastricht University Medical Centre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. dr. Annemie M. Schols, Maastricht University Medical Center, department of Respiratory Medicine
ClinicalTrials.gov Identifier: NCT00840892     History of Changes
Other Study ID Numbers: INTERCOM_CCMO_P00.1631L
Neth Asthma Found., 3.4.01.63
First Submitted: February 10, 2009
First Posted: February 11, 2009
Last Update Posted: February 11, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive