title: The Chronic Care for Wet Age Related Macular Degeneration (CHARMED) Study: A Randomized Controlled Trial.
abstract: BACKGROUND
  In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM).
  
  
  METHODS
  Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using reminder systems, performing structured follow-up, empowering patients in self-monitoring and giving decision-support). In the control usual care was continued. Main outcome measures were changes in ETDRS visual acuity, optical coherence tomography (OCT) macular retinal thickness and quality of life (NEI VFQ-25 questionnaire).
  
  
  RESULTS
  169 consecutive patients in Swiss ophthalmology centers were included. Mean ETDRS baseline visual acuity of eyes with W-AMD was 57.8 (± 18.7). After 12 months, the between-group difference in mean change of ETDRS visual acuity was -4.8 (95%CI: -10.8 to +1.2, p = 0.15); difference in mean change of OCT was +14.0 (95% CI -39.6 to 67.6, p = 0.60); difference in mean change of NEI VFQ-25 composite score mean change was +2.1(95%CI: -1.3 to +5.5, p = 0.19).
  
  
  CONCLUSIONS
  The intervention aiming at improving chronic care was not associated with favorable outcomes within 12 months. Other approaches need to be tested to close the evidence-performance gap in W-AMD.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN32507927.
authors.affiliation: Institute of Primary Care, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Markun
authors.affiliation: Department of Ophthalmology, Cantonal Hospital Aarau, Aarau, Switzerland.
authors.forename: Avraham
authors.initials: A
authors.lastname: Dishy
authors.affiliation: Institute of Primary Care, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Neuner-Jehle
authors.affiliation: Institute of Primary Care, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Rosemann
authors.affiliation: Institute of Primary Care, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.|Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland.
authors.forename: Anja
authors.initials: A
authors.lastname: Frei
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012160:Retina / Q000473:pathology; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity