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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.


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Authors

Farmer, Andrew 
Hardeman, Wendy 
Hughes, Dyfrig 
Prevost, A Toby 
Kim, Youngsuk 

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.

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Keywords

Aged, Blood Glucose, Decision Support Techniques, Diabetes Mellitus, Type 2, Drug Monitoring, England, Female, Health Status Indicators, Health Surveys, Humans, Hypoglycemic Agents, Male, Middle Aged, Outcome Assessment, Health Care, Patient Compliance, Primary Care Nursing, Referral and Consultation, Self Report

Journal Title

BMC Fam Pract

Conference Name

Journal ISSN

1471-2296
1471-2296

Volume Title

Publisher

Springer Science and Business Media LLC
Sponsorship
Medical Research Council (G0500267)
Medical Research Council (MC_UU_12015/4)
NIHR Central Commissioning Facility (NIHRDH-RP-PG-0606-1259)
Medical Research Council (MC_U106179474)