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

根据2015年全球疾病负担研究，糖尿病和慢性肾脏疾病(CKD)分别位居泰国死亡原因第5位和第7位。据估计，2013年泰国有3.2名成年人(占成年人口的6.4%)患有糖尿病，预计到2035年将增至520万人。通过透析治疗晚期肾衰竭的费用很高，2011年约占泰国医疗预算的3.6%，预计到2018年将增加到6.2%。如果及早发现，这种并发症是可以在大多数情况下预防的。尽管泰国实施了全民医疗保险，但医疗保健系统--尤其是为农村人口服务的医疗保健系统--仍然缺乏管理糖尿病的能力，因为医生短缺，而且几乎没有有组织的糖尿病规划。糖尿病相关的肾脏疾病尤其如此。因此，迫切需要在农村地区发现和管理糖尿病的替代方法。一种可能的方法是使用更广泛的卫生保健劳动力，如乡村卫生工作者。这些工人没有医学资格，但接受过健康培训，可能会被用来提供更有效的护理。这项研究将开发和评估一项名为“智能健康”的战略，利用非医生医护人员根据最佳实践识别和管理患有糖尿病和肾脏疾病的乡村居民。医护人员将接受培训，使用一种简单的移动设备(平板电脑或智能手机)，他们可以在上面记录患者的数据，如年龄、体重、血压、家族史，并获得有关如何用电子程序生成的药物和/或生活方式建议来治疗患者的即时建议。该计划考虑患者的风险因素和疾病阶段，并根据国民治疗指南生成建议。该计划还与患者的个人健康记录相联系，以便他们可以根据需要进行跟踪或转介到医院。这项研究将分为两个阶段。在第一阶段，我们将开发和测试用于检测和管理糖尿病的电子程序或“算法”，以确保建议是适当的，并与现有的设施和资源(包括负担得起的药物)保持一致。在第二阶段，我们在一项大型试验中衡量SMART健康糖尿病的有效性，该试验将20个接受过使用和获得SMART健康糖尿病培训的村庄(“干预”村庄)与20个没有SMART健康糖尿病但将继续其惯常做法的村庄(“对照”村庄)进行比较。然后，我们将比较来自干预和村庄的个体在与糖尿病相关的重要结果方面的情况，如血糖控制和肾脏损害。同时，我们会进行经济评估和与医护人员面谈，以确定SMART Health糖尿病是否合乎成本效益和可接受程度。我们会与乡村领袖、政府组织和专业团体合作，确保这项研究切合实际和适当。通过与这些小组的合作，我们还将确保SMART Health糖尿病在被证明有效和安全的情况下更广泛地应用于常规糖尿病护理。

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.