None listed
Conditions
Interventions
The study will be divided into two periods. During the first three-month period, smokers motivated to quit are offered an intensive smoking cessation program. In the second phase, all patients will be
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. FEV1 between 25% and 80% of the predicted value; 2. Three or more exacerbations or one hospitalization in the two years preceding study entry; 3. A signed and dated written informed consent from the subject prior to study participation; 4. Patients of the outpatient clinic of the Medisch Spectrum Twente; 5. Age between 40 and 75 years; 6. A clinical diagnosis of COPD as defined by the GOLD-criteria (9); 7. Stable and well controlled COPD, at least one month before inclusion; 8. Current smoker or ex-smoker; 9. Able to understand, read and write Dutch.
Exclusion criteria
Exclusion criteria: 1. Serious other disease with a low survival rate; 2. Other disease which influences bronchial symptoms and/or lung function (e.g. cardiac insufficiency, sarcoïdosis); 3. Severe psychiatric illness; 4. A disregulation of diabetes mellitus during an exacerbation in the past or a hospitalization for diabetes mellitus in the two years preceding the study; 5. Need for regular oxygen therapy; 6. Maintenance therapy with antibiotics; 7. Known alpha1 antitrypsine deficiency; 8. Disorders or progressive diseases, which influence seriously the ability to walk (e.g. amputation, paralysis, progressive muscle diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effect of self-treatment within a self-management program: Duration and severity of the exacerbations Measured by daily diaries which are filled out by all the patients during the total length of the study; 2. Effect of an exercise program within a self-management program: Functional exercise capacity: Shuttle Walk Test. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life: Chronic Respiratory Questionnaire (CRQ) (Self-Administered Standarised version); 2. Health Status: Clinical COPD Questionnaire (CCQ); 3. Social Support: Social Support List (SSL-12); 4. Anxiety and depression: Hospital Anxiety and Depression Scale (HADS); 5. Self-Efficacy: Self-Efficacy list; 6. Dypnoe: Medical Research Counsil Scale; 7. Lung function: FEV1 FEV1/IVC FEV1/FVC; 8. Percentage of Fat Free Mass: Bioelectrical Impedance Measurements; 9. Utilities: Euroqol 5D + Visual Analogue Scale (VAS); 10. Activity at home: Pedometers; 11. Costs: a. Program costs; b. Direct medical costs (e.g the number of hospitalizations, emergency room visits, doctor consultations, and the medication used for COPD); c. Direct non-medical costs (e.g. travel costs); d. Indirect costs (e.g. lost productivity including usual daily activities and time costs borne by the individual); 12. Number of patients who quitted the COPE-active program: a. During the first 6 months; b. After the 6th month; 13. Adverse events; 14. Co-morbidity, social events, etc. | — |
Contacts
Public ContactJ. Palen, van der
Medisch Spectrum Twente, P.O. Box 50000
Outcome results
None listed