Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
CDLM, visual scale - physician evaluation, COPD, GOLD group C and D
Brief summary
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.
Detailed description
CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD, grade C and D according to GOLD Guidelines Revised 2011 * Current or past smokers, of at least 10 pack years * Receive any inhaled combination therapy for COPD (inhaled corticosteroid / long acting β2-agonist bronchodilator) initiated for at least one month before entering in the study
Exclusion criteria
* History of exacerbation of COPD symptoms within the last month before visit 1, inclusive; history of asthma or allergic rhinitis; history of lung carcinoma or any other respiratory condition that may limit the airflow circulation * Inability to understand study procedures and inability/refuse to complete CDLM questionnaires and/or record the values showed on the pedometer screen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire | Baseline and 3 months | 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). |
| Change from baseline of patient's general health status based upon physician evaluation - visual scale | Baseline and 3 months | 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) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic patient characteristics | Day 0 (visit1) | Demographic patient characteristics are: Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban, rural) |
| Patient adherence to treatment - visual scale | up to 3 months | 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). |
| Number of daily walking steps (using pedometer) | up to 3 months | 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). |
| Number of exacerbations | up to 3 months | 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). |
Countries
Romania
Outcome results
None listed