CorRELation Between PatIent PErception and Findings on Clinical Examination (RELIEF)
Chronic Obstructive Pulmonary Disease (COPD)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients|
- Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]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) .
- Demographic patient characteristics [ Time Frame: Day 0 (visit1) ] [ Designated as safety issue: No ]
Demographic patient characteristics are:
Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban, rural)
- Patient adherence to treatment - visual scale [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
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) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]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).
|Study Start Date:||July 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|COPD patients grade C and D|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627743
|Drobeta Turnu Severin, Romania|
|Ramnicu Valcea, Romania|
|Principal Investigator:||Florin Mihaltan, PROFESSOR||University of Medicine and Pharmacy Carol Davila, Bucharest, Romania|