Validity and Reliability of The Turkish Version of Assessment of Burden of COPD Scale

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ClinicalTrials.gov Identifier: NCT03610659

Recruitment Status : Completed

First Posted : August 1, 2018

Last Update Posted : February 5, 2019

Sponsor:

Information provided by (Responsible Party):

Seda Saka, Bezmialem Vakif University

Study Description

Brief Summary:

In our study, we aimed to evaluate the validity and reliability of the Turkish version of theAssessment of Burden of COPD (ABC) Scale.

Condition or disease
COPD

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 Design

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Study Type :	Observational
Actual Enrollment :	75 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Validity and Reliability of The Turkish Version of Assessment of Burden of COPD Scale
Actual Study Start Date :	June 23, 2018
Actual Primary Completion Date :	December 25, 2018
Actual Study Completion Date :	February 1, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Probability Sample

Study Population

COPD patients

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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): NCT03610659

Locations

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Turkey
Bezmialem Vakıf University
Istanbul, Turkey, 34350

Sponsors and Collaborators

Bezmialem Vakif University

More Information

Publications:

Slok AH, Bemelmans TC, Kotz D, van der Molen T, Kerstjens HA, In 't Veen JC, Chavannes NH, Asijee GM, Rutten-van Mölken 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 Mölken MPMH, Boland MRS, Donkers B, Jonker MF, Slok AHM, Salomé 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.

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Responsible Party:	Seda Saka, MSc, PT, Bezmialem Vakif University
ClinicalTrials.gov Identifier:	NCT03610659
Other Study ID Numbers:	ssaka03
First Posted:	August 1, 2018 Key Record Dates
Last Update Posted:	February 5, 2019
Last Verified:	February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Seda Saka, Bezmialem Vakif University:


COPD Burden of disease

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