title: An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes.
abstract: BACKGROUND
  Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes.
  
  
  METHODS
  This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c ≥ 7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat.
  
  
  RESULTS
  211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction.
  
  
  CONCLUSIONS
  This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice.
authors.affiliation: Department of Primary Health Care Sciences, University of Oxford, Oxford, UK. andrew.farmer@phc.ox.ac.uk
authors.forename: Andrew
authors.initials: A
authors.lastname: Farmer
authors.forename: Wendy
authors.initials: W
authors.lastname: Hardeman
authors.forename: Dyfrig
authors.initials: D
authors.lastname: Hughes
authors.forename: A Toby
authors.initials: AT
authors.lastname: Prevost
authors.forename: Youngsuk
authors.initials: Y
authors.lastname: Kim
authors.forename: Anthea
authors.initials: A
authors.lastname: Craven
authors.forename: Jason
authors.initials: J
authors.lastname: Oke
authors.forename: Sue
authors.initials: S
authors.lastname: Boase
authors.forename: Mary
authors.initials: M
authors.lastname: Selwood
authors.forename: Ian
authors.initials: I
authors.lastname: Kellar
authors.forename: Jonathan
authors.initials: J
authors.lastname: Graffy
authors.forename: Simon
authors.initials: S
authors.lastname: Griffin
authors.forename: Stephen
authors.initials: S
authors.lastname: Sutton
authors.forename: Ann-Louise
authors.initials: AL
authors.lastname: Kinmonth
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects*; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D016903:Drug Monitoring / Q000295:instrumentation; D004739:England; D005260:Female; D006305:Health Status Indicators; D006306:Health Surveys; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data; D010349:Patient Compliance / Q000523:psychology / Q000706:statistics & numerical data*; D059017:Primary Care Nursing / Q000379:methods*; D012017:Referral and Consultation; D057566:Self Report
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents