Abstract
BackgroundPoor 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/designThe 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.DiscussionThis 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.Trial registrationCurrent Controlled Trials: ISRCTN89683704
Highlights
Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy
Methods/design The purpose of this study was to determine whether additional education and advice about glaucoma using a Behaviour Change Counselling (BCC) intervention, improves adherence with topical antiglaucomatous therapy
Predictors of adherence Information about baseline socio-demographic characteristics and the following possible predictors of adherence were collected using a structured interview; a positive family history of glaucoma, previous use of eye drops, use of other prescribed medication and if this was used at the same time as travoprost, and self-administration of drops or help given by a family member
Summary
Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy. The chronic and complex nature of glaucoma means that patient non-adherence to glaucoma therapy does not correlate with measureable objective clinical endpoints. Patient non-adherence with anti-glaucoma therapy is poorly understood with reported rates between 5% and 80% [7]. Non-adherence has been categorised as intentional or unintentional, but the ultimate behaviour is often an amalgam of these factors [8]. Unintentional non-adherence is a passive process that prevents use of medication as intended by the prescriber, such as forgetfulness, poor comprehension of dosing regimen or physical inability to self-administer medication. Intentional non-adherence is a deliberate decision by the patient to deviate from the prescribed recommendations by not taking medication, reducing the dosing frequency or premature discontinuation
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