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This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice, the possible corelation between patIent perception of the ability to perform morning activities and physician evaluation; patients with COPD, grade C and D.
CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients grade C and D |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire | CDLM questionnaire is a simple self-reporting tool of the burden and ability of COPD patients to perform routine morning activities: washing, dressing, eating breakfast, walking around. For each of these morning activities the score is varying from 0 (indicating worst case) to 5 (indicating best case). | Baseline and 3 months |
| Change from baseline of patient's general health status based upon physician evaluation - visual scale | General health status visual scale is assessing the physicians perception of the patient health status following the clinical examination. Based upon clinical evaluation, the physician will indicate the patient's general condition on a a scale consisting of 5 levels. The scale will be completed at each visit and the score can vary from 1(very bad general health status) to 5 (very good general health status) . | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic patient characteristics | Demographic patient characteristics are: Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban, rural) | Day 0 (visit1) |
| Patient adherence to treatment - visual scale |
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Inclusion Criteria:
Exclusion Criteria:
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COPD patients, group C and D according to GOLD guidelines 2011, being treated for at least 1 month with combination ICS/LABA treatment
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| Name | Affiliation | Role |
|---|---|---|
| Florin Mihaltan, PROFESSOR | University of Medicine and Pharmacy Carol Davila, Bucharest, Romania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bacau | Romania | ||||
| Research Site |
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The physician will evaluate adherence to treatment, after discussion with patient, by completing a visual scale for evaluation patient's adherence to treatment (adherence will be assessed in percentage, by indicating at the scale the value from 0% to 100% adherence).
The visual scale has the following cut-off points: 0% (no adherence to treatment), 25% (poor adherence), 50% (medium adherence), 75% (good adherence), 100% (high adherence).
| up to 3 months |
| Number of daily walking steps (using pedometer) | The pedometers register the total daily walking steps. Each morning, the subject will reset the device by pressing the on/reset button. At the end of the day, the patient will record the number of daily walking steps. The estimated value for number of walking steps is 2,500 - 4,500 steps/day (based on previous studies). | up to 3 months |
| Number of exacerbations | Exacerbation is defined as a worsening of COPD symptoms that is beyond day-to-day variations and that requires antibiotic treatment and/or short systemic corticoid treatment and/or emergency room visit with or without hospital admission (according to GOLD criteria and previous studies). | up to 3 months |
| Botoșani |
| Romania |
| Research Site | Bucharest | Romania |
| Research Site | Buzău | Romania |
| Research Site | Calarasi | Romania |
| Research Site | Cluj-Napoca | Romania |
| Research Site | Constanța | Romania |
| Research Site | Craiova | Romania |
| Research Site | Drobeta-Turnu Severin | Romania |
| Research Site | Fălticeni | Romania |
| Research Site | Focşani | Romania |
| Research Site | Iași | Romania |
| Research Site | Leordeni | Romania |
| Research Site | Luduş | Romania |
| Research Site | Oradea | Romania |
| Research Site | Ploieşti | Romania |
| Research Site | Râmnicu Vâlcea | Romania |
| Research Site | Reghin | Romania |
| Research Site | Slatina | Romania |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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