(Cost-)Effectiveness Interdisciplinary Community-based COPD Management Program (INTERCOM)
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|ClinicalTrials.gov Identifier: NCT00840892|
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : February 19, 2018
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 or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Other: INTERdisciplinary COMmunity-based COPD management (INTERCOM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-based COPD Management Program Relative to Usual Care.|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||March 2007|
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|
- 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
- dyspnea, quality of life, exercise performance measures, body composition measures and lung function
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
|Maxima Medical Centre|
|Principal Investigator:||Annemie MWJ Schols, Prof PhD||Maastricht University Medical Centre|