Skip to main content
OpenTrials
Completed

NCT Number: NCT01627743

CorRELation Between PatIent PErception and Findings on Clinical Examination

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Bacau, Romania

Loading trial locations.

About this study

CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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) .

Secondary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients

Acronym: RELIEF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2012
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.