(Cost-)Effectiveness Interdisciplinary Community-Based COPD Management Program (INTERCOM)
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| First Received Date ICMJE | February 10, 2009 | ||||
| Last Updated Date | February 10, 2009 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
dyspnea, quality of life, exercise performance measures, body composition measures and lung function | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | (Cost-)Effectiveness Interdisciplinary Community-Based COPD Management Program (INTERCOM) | ||||
| Official Title ICMJE | Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-Based COPD Management Program Relative to Usual Care. | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Pulmonary Disease, Chronic Obstructive | ||||
| Intervention ICMJE | 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. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 199 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00840892 | ||||
| Other Study ID Numbers ICMJE | INTERCOM_CCMO_P00.1631L, Neth Asthma Found., 3.4.01.63 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Prof. dr. Annemie M. Schols, Maastricht University Medical Center, department of Respiratory Medicine | ||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||
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| Information Provided By | Maastricht University Medical Center | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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