Abstract
BackgroundNeovascular age-related macular degeneration is the leading cause of irreversible blindness in people 50 years of age or older in the developed world. As in other chronic diseases, several effective treatments are available, but in clinical daily practice there is an evidence performance gap. The Chronic Care Model represents an evidence-based framework for the care of chronically ill patients and aims at closing that gap. However, no data are available regarding patients with neovascular age-related macular degeneration.Methods/DesignCHARMED is a multicenter randomized controlled trial. The study challenges the hypothesis that the implementation of core elements of the Chronic Care Model (patient empowerment, delivering evidence based information, clinical information system, reminder system with structured follow up and frequent monitoring) via a specially trained Chronic Care Coach in Swiss centres for neovascular age-related macular degeneration results in better visual acuity (primary outcome) and an increased disease specific quality of life (secondary outcome) in patients with neovascular age-related macular degeneration. According to the power calculation, a total sample size of 352 patients is needed (drop out rate of 25%). 14 specialised medical doctors from leading ophtalmologic centres in Switzerland will include 25 patients. In each centre, a Chronic Care Coach will provide disease specific care according to the Chronic Care Model for intervention group. Patients from the control group will be treated as usual. Baseline measurements will be taken in month III - XII, starting in March 2011. Follow-up data will be collected after 6 months and 1 year.DiscussionMultiple studies have shown that implementing Chronic Care Model elements improve clinical outcomes as well as process parameters in different chronic diseases as osteoarthritis, depression or e.g. the cardiovascular risk profile of diabetes patients. This study will be the first to assess this approach in neovascular age-related macular degeneration. If our hypothesis will be confirmed, the implementation of this approach in routine care for patients with with neovascular age-related macular degeneration should be considered.Trial RegistrationCurrent controlled trials ISRCTN32507927.
Highlights
Neovascular age-related macular degeneration is the leading cause of irreversible blindness in people 50 years of age or older in the developed world
Multiple studies have shown that implementing Chronic Care Model elements improve clinical outcomes as well as process parameters in different chronic diseases as osteoarthritis, depression or e.g. the cardiovascular risk profile of diabetes patients
This study will be the first to assess this approach in neovascular age-related macular degeneration
Summary
The CCM has achieved widespread acceptance as an evidence based template for the care of chronically ills. Wet AMD has the same characteristics as the diseases for which the CCM has been established as e.g. diabetes: Its natural course leads to a continuous loss in visual acuity. On the other hand there are established treatments available The effectiveness of these treatments largely depends on a frequent application. Similar to diabetes, where a frequent follow-up and a proactive approach with action before the disease gets worse is effective, wet AMD has to be treated before visual acuity gets worse or completely lost. It can be assumed that some of the elements of the CCM, mainly the frequent follow up by a structured case management, will result in better clinical outcomes. Multiple studies have shown that implementing CCM elements improve clinical outcomes as well as process parameters in different chronic diseases as osteoarthritis, depression or e.g. the cardiovascular risk profile of diabetes patients. If our hypothesis will be confirmed, the implementation of this approach in routine care for patients with wet AMD should be considered
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