title: Protocol for a randomised controlled trial to estimate the effects and costs of a patient centred educational intervention in glaucoma management.
abstract: BACKGROUND
  Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy. However, the multi-factorial nature of non-adherent behaviour may explain the failure of purely educational interventions to achieve significant improvement in adherence. Behaviour Change Counselling (BCC) allows both the imparting of information and assessment of patient ambivalence to medication use and may elicit behaviour change in order to achieve better adherence. The chronic and complex nature of glaucoma means that patient non-adherence to glaucoma therapy does not easily correlate with measureable objective clinical endpoints. However, electronic medication monitoring offers an objective method of measuring adherence without reliance on clinical endpoints.
  
  
  METHODS
  The study is a randomised controlled trial (RCT) with glaucoma (open angle) or ocular hypertension patients attending a glaucoma clinic and prescribed travoprost. The study will determine whether additional glaucoma education using BCC is beneficial and cost effective in improving adherence with glaucoma therapy. An 8-month follow-up period, using an electronic adherence monitoring device (Travalert dosing aid, TDA), will indicate if the intervention is likely to be sustained in the longer term. Additionally, a cost-effectiveness framework will be used to estimate the cost benefit of improving adherence. The development of a novel intervention to deliver glaucoma education using BCC required practitioner training and fidelity testing. Five practitioners were successfully trained to become Glaucoma Support Assistants able to deliver the BCC intervention. The research group had prior clinical and investigative experience in this setting, and used multiple strategies to design a method to address the study objectives.
  
  
  CONCLUSIONS
  This RCT, using BCC to improve adherence to ocular hypotensive therapy, to our knowledge is the first within this disease area. Using a variety of adherence measures allows examination of the known inaccuracies of patient self-report with respect to glaucoma medication. The novel BCC component has undergone fidelity testing using BECCI and the BCC template will ensure conformity to a standardised intervention.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN89683704.
authors.affiliation: Ophthalmology, Norfolk & Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7UY, UK. heidi.cate@nnuh.nhs.uk
authors.forename: Heidi
authors.initials: H
authors.lastname: Cate
authors.forename: Debi
authors.initials: D
authors.lastname: Bhattacharya
authors.forename: Allan
authors.initials: A
authors.lastname: Clark
authors.forename: Richard
authors.initials: R
authors.lastname: Fordham
authors.forename: Caitlin
authors.initials: C
authors.lastname: Notley
authors.forename: David C
authors.initials: DC
authors.lastname: Broadway
mesh_terms: D000959:Antihypertensive Agents / Q000191:economics / Q000627:therapeutic use; D002985:Clinical Protocols; D003008:Cloprostenol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015928:Cognitive Behavioral Therapy / Q000191:economics*; D003362:Cost-Benefit Analysis; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000191:economics / Q000628:therapy*; D006801:Humans; D055118:Medication Adherence; D009798:Ocular Hypertension / Q000191:economics / Q000628:therapy*; D010353:Patient Education as Topic / Q000191:economics / Q000379:methods*; D000069557:Travoprost
chemical_list: D000959:Antihypertensive Agents; D003008:Cloprostenol; D000069557:Travoprost