Protocol of economic evaluation and equity impact analysis of mHealth and community groups for prevention and control of diabetes in rural Bangladesh in a three-arm cluster randomised controlled trial.

Abstract

Type 2 diabetes mellitus (T2DM) is one of the leading causes of death and disability worldwide, generating substantial economic burden for people with diabetes and their families, and to health systems and national economies. Bangladesh has one of the largest numbers of adults with diabetes in the South Asian region. This paper describes the planned economic evaluation of a three-arm cluster randomised control trial of mHealth and community mobilisation interventions to prevent and control T2DM and non-communicable diseases' risk factors in rural Bangladesh (D-Magic trial). The economic evaluation will be conducted as a within-trial analysis to evaluate the incremental costs and health outcomes of mHealth and community mobilisation interventions compared with the status quo. The analyses will be conducted from a societal perspective, assessing the economic impact for all parties affected by the interventions, including implementing agencies (programme costs), healthcare providers, and participants and their households. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of intermediate hyperglycaemia and T2DM prevented and cost per case of diabetes prevented among individuals with intermediate hyperglycaemia at baseline and cost per mm Hg reduction in systolic blood pressure. In addition to ICERs, the economic evaluation will be presented as a cost-consequence analysis where the incremental costs and all statistically significant outcomes will be listed separately. Robustness of the results will be assessed through sensitivity analyses. In addition, an analysis of equity impact of the interventions will be conducted. The approval to conduct the study was obtained by the University College London Research Ethics Committee (4766/002) and by the Ethical Review Committee of the Diabetic Association of Bangladesh (BADAS-ERC/EC/t5100246). The findings of this study will be disseminated through different means within academia and the wider policy sphere. ISRCTN41083256; Pre-results.