Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03610659
Other study ID # ssaka03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 23, 2018
Est. completion date February 1, 2019

Study information

Verified date February 2019
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date February 1, 2019
Est. primary completion date December 25, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06000696 - Healthy at Home Pilot
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04105075 - COPD in Obese Patients
Recruiting NCT05825261 - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting NCT04075331 - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial Phase 2/Phase 3
Terminated NCT03640260 - Respiratory Regulation With Biofeedback in COPD N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn NCT04210050 - Sleep Ventilation for Patients With Advanced Hypercapnic COPD N/A
Terminated NCT03284203 - Feasibility of At-Home Handheld Spirometry N/A
Recruiting NCT06110403 - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness Phase 1/Phase 2
Active, not recruiting NCT06040424 - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Completed NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A
Completed NCT04119856 - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD N/A
Completed NCT04485741 - Strados System at Center of Excellence
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT04860375 - Multidisciplinary Management of Severe COPD N/A