title: Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial.
abstract: OBJECTIVE
  To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice.
  
  
  METHODS
  24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial.
  
  
  METHODS
  15 general practices in the eastern part of the Netherlands.
  
  
  METHODS
  Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded.
  
  
  METHODS
  A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative).
  
  
  METHODS
  The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale.
  
  
  RESULTS
  165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58).
  
  
  CONCLUSIONS
  Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group.
  
  
  BACKGROUND
  Clinical trials NCT00128765.
authors.affiliation: Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, P O Box 9101, 6500 HB Nijmegen, Netherlands. E.Bischoff@elg.umcn.nl
authors.forename: Erik W M A
authors.initials: EW
authors.lastname: Bischoff
authors.forename: Reinier
authors.initials: R
authors.lastname: Akkermans
authors.forename: Jean
authors.initials: J
authors.lastname: Bourbeau
authors.forename: Chris
authors.initials: C
authors.lastname: van Weel
authors.forename: Jan H
authors.initials: JH
authors.lastname: Vercoulen
authors.forename: Tjard R J
authors.initials: TR
authors.lastname: Schermer
mesh_terms: D000368:Aged; D019468:Disease Management; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D058006:General Practice / Q000379:methods*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011788:Quality of Life; D012648:Self Care / Q000379:methods*; D013147:Spirometry; D011795:Surveys and Questionnaires