Cost effectiveness of a health literacy intervention to reduce HbA1c level among type 2 diabetes mellitus patients in Hospital Angkatan Tentera Tuanku Mizan

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Malaysian diabetic patients are mostly poorly controlled, with a mean hemoglobin A1c (HbA1c) of 8.7% and only 22% of patients achieving the treatment goal of <6.5%.Clearly, an improvement in glycemic control is likely to reduce the risk of diabetic complications. Diabetic education is one of the approach to achieve HbA1c target. It is effective for improving clinical outcomes and quality of life of patients with diabetes. Health literacy targeted intervention is one type of diabetic education approach which integrate self-efficacy and self-care behavior into the module. It is targeted towards diabetic patients who have medium to low health literacy. The objective of this study is to develop, implement and evaluate the health literacy targeted intervention on reducing HbA1c level and cost effectiveness of the intervention among Type 2 Diabetes Mellitus patients at Hospital Angkatan Tentera Tuanku Mizan. This study will be carried out at Hospital Angkatan Tentera Tuanku Mizan (HATTM), specifically at Medical Outpatient Department (MOPD) and primary care centre of HATTM at Kem Kementah. Study design is parallel, single blind, randomized control trial will be used. There will be two arms, there are the intervention arm (receiving the Diabetes Literacy and Numeracy Toolkit (DLNET) module) and control arm (receiving the usual Diabetes Education module). Inclusion criteria will be confirmed patients with T2DM (within 6 months), adult ( Age more than 18 years old), able to understand English or Malay language, low health literacy (NVS score less than 4) and baseline HbA1c higher or equal to 6.5%. Exclusion criteria are patients who has psychiatric problem (e.g schizophrenia), high health literacy (NVS score more than 3), corrected visual acuity of less than 20/50 using a Rosenbaum Screener and color blinded. Sample size estimation is 58 participants for each arm. Data analysis will be done in different stages, with in subject analysis and between subject analyses. A General Linear Model (GLM) will be used for outcome without covariates and with covariates. Multivariate analysis of covariance (MANCOVA) will be used to see the different between controlling the covariates (after post hoc test) and without controlling the covariates (before post hoc test). Spearman correlation will be used to analysis correlation between self-efficacy and self-care. The independent variable of this study is DLNET intervention, intermediate dependent variables are self-efficacy score and self-care score and main dependent variable is HbA1c. Cost effectiveness analysis will be performed using cost effectiveness ratio

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