Trial to Incentivise Adherence for Diabetes (TRIAD): study protocol for a randomised controlled trial

Abstract

BACKGROUND: Many people with diabetes have suboptimal glycaemic control due to not being adherent to their treatment regimen. Behavioural economic theory suggests that the lack of adherence results from the disconnect between the timing of when costs and benefits accrue. One strategy to address this discontinuity is to offer patients a near-term benefit, such as a financial reward. Whereas there is evidence that rewards can improve treatment adherence and sometimes health outcomes, further research is needed to determine whether rewards are more effective when targeting processes or intermediary health outcomes. In the Trial to Incentivise Adherence for Diabetes (TRIAD) we test whether adding financial incentives to usual care can improve HbA1c levels among people with diabetes and whether the financial incentives work better when targeting processes (adherence to blood glucose testing, medication, and daily physical activity) or the primary intermediary health outcome of self-monitored blood glucose within an acceptable range. METHODS/DESIGN: TRIAD is a randomised, controlled, open-label, single-centre superiority trial with three parallel arms. A total of 240 patients with suboptimally controlled diabetes (HbA1c ≥ 8%) from a polyclinic in Singapore are block-randomised (blocking factor: current vs. new glucometer users) into three arms, namely (1) usual care (UC) only, (2) UC with process incentive and (3) UC with outcome incentive, in a 2:3:3 ratio. Masking the arm allocation will be precluded by the behavioural nature of the intervention but blocking size will not be disclosed to protect concealment. The primary outcome (change in HbA1c level at month 6) will be measured by a laboratory that is independent from the study team. Secondary outcomes (at month 6) include the number of blood glucose testing days, glucose readings within the normal range (between 4 to 7 mmol/L), medication-adherent days, physically active days, and average incentives earned and time spent administrating the incentives. DISCUSSION: This study will provide evidence on whether financial incentives can cost-effectively improve glycaemic control. It will also provide evidence on the benefit incidence of interventions involving financial incentives. By comparing process to outcome incentives, this study will inform the design of future incentive strategies in chronic disease management and beyond. TRIAL REGISTRATION: ClinicalTrials.gov registry, ID: NCT02224417 . Registered on 22 August 2014.