NCT03610659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

July 26, 2018

Last Update Submit

February 1, 2019

Conditions

Keywords

COPDBurden of disease

Outcome Measures

Primary Outcomes (1)

  • Assessment of Burden of COPD (ABC) Scale

    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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD patients

You may qualify if:

  • FEV1/FVC\<%70
  • To be able to read and understand Turkish

You may not qualify if:

  • Having undergone a COPD exacerbation in the last 6 weeks
  • Having comorbidities affecting ambulance
  • Having cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34350, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26788838BACKGROUND
  • 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.

    PMID: 29282261BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 1, 2018

Study Start

June 23, 2018

Primary Completion

December 25, 2018

Study Completion

February 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations