Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
OTHERINTERdisciplinary 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.
Sponsors
Maxima Medical Center
Erasmus Medical Center
The Netherlands Asthma Foundation
Stichting Astma Bestrijding, The Netherlands
Nutricia Netherlands
PICASSO: Partners in Care Solutions for COPD
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| dyspnea, quality of life, exercise performance measures, body composition measures and lung function | — |
Countries
Netherlands
Outcome results
None listed