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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00840892
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 10, 2009
February 10, 2009
January 2002
Not Provided
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
Same as current
No Changes Posted
dyspnea, quality of life, exercise performance measures, body composition measures and lung function
Same as current
Not Provided
Not Provided
 
(Cost-)Effectiveness Interdisciplinary Community-Based COPD Management Program (INTERCOM)
Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-Based COPD Management Program Relative to Usual Care.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
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.
  • Experimental: Intercom
    INTERdisciplinary COMmunity-based COPD management (INTERCOM)
    Intervention: Other: INTERdisciplinary COMmunity-based COPD management (INTERCOM)
  • No Intervention: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
March 2007
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00840892
INTERCOM_CCMO_P00.1631L, Neth Asthma Found., 3.4.01.63
Not Provided
Prof. dr. Annemie M. Schols, Maastricht University Medical Center, department of Respiratory Medicine
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
Principal Investigator: Annemie MWJ Schols, Prof PhD Maastricht University Medical Centre
Maastricht University Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP