CorRELation Between PatIent PErception and Findings on Clinical Examination (RELIEF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01627743
First received: June 22, 2012
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) .


Secondary Outcome Measures:
  • 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).


Enrollment: 505
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD patients 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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

COPD patients, group C and D according to GOLD guidelines 2011, being treated for at least 1 month with combination ICS/LABA treatment

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627743

Locations
Romania
Research Site
Bacau, Romania
Research Site
Botosani, Romania
Research Site
Bucuresti, Romania
Research Site
Buzau, Romania
Research Site
Calarasi, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Constanta, Romania
Research Site
Craiova, Romania
Research Site
Drobeta Turnu Severin, Romania
Research Site
Falticeni, Romania
Research Site
Focsani, Romania
Research Site
Iasi, Romania
Research Site
Leordeni, Romania
Research Site
Ludus, Romania
Research Site
Oradea, Romania
Research Site
Ploiesti, Romania
Research Site
Ramnicu Valcea, Romania
Research Site
Reghin, Romania
Research Site
Slatina, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Florin Mihaltan, PROFESSOR University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01627743     History of Changes
Other Study ID Numbers: NIS-RRO-ATC-2012/1
Study First Received: June 22, 2012
Last Updated: February 20, 2013
Health Authority: Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices

Keywords provided by AstraZeneca:
CDLM
visual scale - physician evaluation
COPD
GOLD group C and D

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014