CorRELation Between PatIent PErception and Findings on Clinical Examination (RELIEF)
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|ClinicalTrials.gov Identifier: NCT01627743|
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : February 21, 2013
|Condition or disease|
|Chronic Obstructive Pulmonary Disease (COPD)|
|Study Type :||Observational|
|Actual Enrollment :||505 participants|
|Official Title:||CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
|COPD patients grade C and D|
- Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire [ Time Frame: 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 [ Time Frame: 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) .
- Demographic patient characteristics [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627743
|Drobeta Turnu Severin, Romania|
|Ramnicu Valcea, Romania|
|Principal Investigator:||Florin Mihaltan, PROFESSOR||University of Medicine and Pharmacy Carol Davila, Bucharest, Romania|