A cluster randomised trial of an innovative, low-cost primary care programme for the detection and management of type 2 diabetes in rural Thailand

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Diabetes and chronic kidney disease (CKD) were ranked 5th and 7th leading cause of mortality in Thailand by the Global Burden of Disease Study 2015. An estimated 3.2 Thai adults (6.4% of the adult population) had diabetes in 2013, expected to grow to 5.2 million by 2035. Treatment of advanced kidney failure by dialysis is expensive, costing about 3.6% of the Thai healthcare budget in 2011, projected to increase to 6.2% by the year 2018. If detected early, this complication can be prevented in a majority. Despite the implementation of universal health coverage in Thailand, the health care systems - particularly those serving rural populations - remain poorly equipped to manage diabetes because doctors are in short supply and there are few organised diabetes programmes. This is especially true for diabetes-related kidney disease. Therefore, alternative methods of detecting and managing diabetes in rural areas are urgently required. One potential method is to use a more widely available health care workforce such as village health workers. These workers are not medically qualified but have received health training workers and could potentially be used to deliver more effective care. This study will develop and assess a strategy called 'SMART Health' to use non-physician healthcare workers to identify and manage village residents with diabetes and kidney disease according to best practice. Healthcare workers will be trained to use a simple mobile device (tablet or smartphone) on which they can record patient data such as age, weight, blood pressure, family history and receive immediate advice about how to treat the patient with drugs and/or lifestyle advice generated by an electronic program. This program considers the patient's risk factors and stage of disease and generates recommendations based on national treatment guidelines. The program also links with the patient's personal health record so that they can be followed up or referred to hospitals as appropriate.The study will have 2 phases. In the first phase, we will develop and test the electronic programmes or 'algorithms' to detect and manage diabetes ensuring that the recommendations are appropriate and in line with the facilities and resources (including affordable medicines) available. In the second phase, we measure the effectiveness of SMART Health Diabetes in a large trial which compares 20 villages who have been trained to use and have access to SMART Health Diabetes ('intervention' villages) with 20 villages who do not have SMART Health Diabetes but will continue their usual practice ('control' villages). We will then compare individuals from intervention and villages in terms important diabetes-related outcomes such as glucose control and kidney damage. In parallel, we will conduct economic assessments and interviews with health workers to determine whether SMART Health Diabetes is cost-effective and acceptable.We will work with village leaders, government organisations and professional groups to make sure the study is relevant and appropriate. By working with these groups, we will also ensure that SMART Health Diabetes can be used more widely in routine diabetes care if proven to be effective and safe.