CorRELation Between PatIent PErception and Findings on Clinical Examination

AstraZeneca505 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

505

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (19)

Research Site

Bacau, Romania

Research Site

Botoșani, Romania

Research Site

Bucharest, Romania

Outcomes

Primary Outcomes

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).

Time frame: 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) .

Time frame: Baseline and 3 months

Secondary Outcomes

Demographic patient characteristics

Demographic patient characteristics are: Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban, rural)

Time frame: Day 0 (visit1)

Patient adherence to treatment - visual scale

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).

Time frame: 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).

Data from ClinicalTrials.gov

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