title: Effectiveness of the Assessment of Burden of Chronic Obstructive Pulmonary Disease (ABC) tool: study protocol of a cluster randomised trial in primary and secondary care.
abstract: BACKGROUND
  Chronic Obstructive Pulmonary Disease (COPD) is a growing worldwide problem that imposes a great burden on the daily life of patients. Since there is no cure, the goal of treating COPD is to maintain or improve quality of life. We have developed a new tool, the Assessment of Burden of COPD (ABC) tool, to assess and visualize the integrated health status of patients with COPD, and to provide patients and healthcare providers with a treatment algorithm. This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary. The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months.
  
  
  METHODS
  A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands. An intervention group, receiving care based on the ABC tool, will be compared with a control group receiving usual care. The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire, the Saint George Respiratory Questionnaire. Secondary outcomes will be a different questionnaire (the COPD Assessment Test), lung function and number of exacerbations. During the 18 months follow-up, seven measurements will be conducted, including a baseline and final measurement. Patients will receive questionnaires to be completed at home. Additional data, such as number of exacerbations, will be recorded by the patients' healthcare providers. A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists. Additionally, a process evaluation will be performed among patients and healthcare providers.
  
  
  CONCLUSIONS
  The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines, which describe the necessity to classify patients on both their airway obstruction and a comprehensive symptom assessment. It has been developed to classify patients, but also to provide visual insight into the burden of COPD and to provide treatment advice.
  
  
  BACKGROUND
  Netherlands Trial Register, NTR3788.
authors.affiliation: Department of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, PO Box 616, 6200 MD Maastricht, The Netherlands. annerika.slok@maastrichtuniversity.nl.
authors.forename: Annerika H M
authors.initials: AH
authors.lastname: Slok
authors.forename: Johannes C C M
authors.initials: JC
authors.lastname: In 't Veen
authors.forename: Niels H
authors.initials: NH
authors.lastname: Chavannes
authors.forename: Thys
authors.initials: T
authors.lastname: van der Molen
authors.forename: Maureen Pmh Rutten-van
authors.initials: MP
authors.lastname: Mölken
authors.forename: Huib A M
authors.initials: HA
authors.lastname: Kerstjens
authors.forename: Guus M
authors.initials: GM
authors.lastname: Asijee
authors.forename: Philippe L
authors.initials: PL
authors.lastname: Salomé
authors.forename: Sebastiaan
authors.initials: S
authors.lastname: Holverda
authors.forename: Richard P N
authors.initials: RP
authors.lastname: Dekhuijzen
authors.forename: Denise
authors.initials: D
authors.lastname: Schuiten
authors.forename: Gerard
authors.initials: G
authors.lastname: van Breukelen
authors.forename: Daniel
authors.initials: D
authors.lastname: Kotz
authors.forename: Onno C P
authors.initials: OC
authors.lastname: van Schayck
mesh_terms: D000465:Algorithms; D017281:Cost of Illness; D018450:Disease Progression; D006801:Humans; D009426:Netherlands; D011320:Primary Health Care; D017064:Process Assessment, Health Care; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D063127:Secondary Health Care; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
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