- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03610659
Validity and Reliability of The Turkish Version of Assessment of Burden of COPD Scale
February 1, 2019 updated by: Seda Saka, Bezmialem Vakif University
In our study, we aimed to evaluate the validity and reliability of the Turkish version of theAssessment of Burden of COPD (ABC) Scale.
Study Overview
Status
Completed
Conditions
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a common pulmonary disease characterized by airway limitation, irreversible, preventable, and treatable (1,2).
COPD is a major health problem that affects the entire world and is expected to be the fourth, the seventh, cause of death in 2030 (3).
The concept of "holistic assessment of disease burden" is widely used to support the personalized care management of COPD patients.
Disease burden; physical, psychological, emotional and / or social burden felt by the patient.
When the questionnaires in the literature evaluating the quality of life / health status in COPD patients were examined, it was seen that none of these questionnaires included all aspects of COPD burden definition (4).
Clinical COPD Questionnaire (CCQ) is a 10-question questionnaire that assesses COPD burden in most aspects and situations.
Assessment of Burden of COPD (ABC) Scale was developed to evaluate the burden of disease in COPD patients by adapting this questionnaire.
The ABC scale was formed by combining three items (a short tool for early identification of distress) and a substance that measures fatigue with the questions of the CCQ scale.
As a result, a scale of 14 items with 5 fields was formed.
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34350
- Bezmialem Vakıf University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
COPD patients
Description
Inclusion Criteria:
- FEV1/FVC<%70
- To be able to read and understand Turkish
Exclusion Criteria:
- Having undergone a COPD exacerbation in the last 6 weeks
- Having comorbidities affecting ambulance
- Having cognitive disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Burden of COPD (ABC) Scale
Time Frame: 3 Minutes
|
The ABC scale is a 14-item newly developed COPD burden assessment questionnaire that the person responds to on their own.
The scale includes questions that are objective determinants of COPD disease burden integrated with the health status of the patient.
There is a total score and 5 subtitle scores; symptoms (4 items), functional status (4 items), mental condition (2 items), emotional condition (3 items) and fatigue (1 item).
Scoring is done between 0 and 6 (0 = no disease burden, 6 = high disease burden).
|
3 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Slok AH, Bemelmans TC, Kotz D, van der Molen T, Kerstjens HA, In 't Veen JC, Chavannes NH, Asijee GM, Rutten-van Molken MP, van Schayck OC. The Assessment of Burden of COPD (ABC) Scale: A Reliable and Valid Questionnaire. COPD. 2016 Aug;13(4):431-8. doi: 10.3109/15412555.2015.1118025. Epub 2016 Jan 20.
- Goossens LMA, Rutten-van Molken MPMH, Boland MRS, Donkers B, Jonker MF, Slok AHM, Salome PL, van Schayck OCP, In 't Veen JCCM, Stolk EA; research team that developed the ABC tool.. ABC Index: quantifying experienced burden of COPD in a discrete choice experiment and predicting costs. BMJ Open. 2017 Dec 26;7(12):e017831. doi: 10.1136/bmjopen-2017-017831.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2018
Primary Completion (Actual)
December 25, 2018
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
July 26, 2018
First Submitted That Met QC Criteria
July 26, 2018
First Posted (Actual)
August 1, 2018
Study Record Updates
Last Update Posted (Actual)
February 5, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ssaka03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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