Research article

BMC Family Practice

, 13:30

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

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

  • Andrew FarmerAffiliated withDepartment of Primary Health Care Sciences, University of Oxford Email author 
  • , Wendy HardemanAffiliated withGeneral Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge
  • , Dyfrig HughesAffiliated withCentre for Health Economics and Medicines Evaluation, Bangor University
  • , A Toby PrevostAffiliated withDepartment of Primary Care and Public Health Sciences, King’s College London
  • , Youngsuk KimAffiliated withGeneral Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge
  • , Anthea CravenAffiliated withDepartment of Primary Health Care Sciences, University of Oxford
  • , Jason OkeAffiliated withDepartment of Primary Health Care Sciences, University of Oxford
  • , Sue BoaseAffiliated withGeneral Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge
  • , Mary SelwoodAffiliated withDepartment of Primary Health Care Sciences, University of Oxford
    • , Ian KellarAffiliated withGeneral Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge
    • , Jonathan GraffyAffiliated withGeneral Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge
    • , Simon GriffinAffiliated withMRC Clinical Epidemiology Unit
    • , Stephen SuttonAffiliated withGeneral Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge
    • , Ann-Louise KinmonthAffiliated withGeneral Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge

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.

Trial registration

Current Controlled Trials ISRCTN30522359

Keywords

Adherence Brief intervention Diabetes