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）分别是泰国第5和第7大死亡原因。2013年，估计有320名泰国成年人（占成年人口的6.4%）患有糖尿病，预计到2035年将增加到520万。通过透析治疗晚期肾衰竭费用昂贵，2011年约占泰国医疗保健预算的3.6%，预计到2018年将增加到6.2%。如果及早发现，这种并发症在大多数情况下是可以预防的。尽管在泰国实施了全民健康覆盖，但是卫生保健系统——特别是那些为农村人口服务的卫生保健系统——仍然缺乏管理糖尿病的装备，因为医生供不应求，而且几乎没有有组织的糖尿病规划。对于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。一种可能的方法是利用更广泛可用的卫生保健人力，如村卫生工作者。这些工作人员没有医疗资格，但接受过卫生培训，可能被用来提供更有效的护理。这项研究将制定和评估一项名为“SMART Health”的战略，利用非医师卫生保健工作者根据最佳做法识别和管理患有糖尿病和肾病的村庄居民。医护人员将接受培训，学会使用一种简单的移动设备（平板电脑或智能手机），在这种设备上他们可以记录病人的数据，如年龄、体重、血压、家族史，并立即收到有关如何用药物治疗病人的建议和/或电子程序生成的生活方式建议。该方案考虑患者的风险因素和疾病阶段，并根据国家治疗指南提出建议。该方案还与患者的个人健康记录相联系，以便他们可以进行随访或酌情转介到医院。这项研究将分为两个阶段。在第一阶段，我们将开发和测试电子程序或“算法”，以检测和管理糖尿病，确保建议是适当的，并符合现有的设施和资源（包括负担得起的药物）。在第二阶段，我们在一项大型试验中衡量SMART Health Diabetes的有效性，该试验将20个接受过SMART Health Diabetes使用培训并可获得SMART Health Diabetes的村庄（“干预”村庄）与20个没有SMART Health Diabetes但将继续其常规做法的村庄（“对照”村庄）进行比较。然后，我们将比较来自干预组和村庄的个体在血糖控制和肾损害等重要的糖尿病相关结果方面的差异。同时，我们将进行经济评估并与卫生工作者面谈，以确定SMART健康糖尿病是否具有成本效益和可接受性。我们会与村领导、政府机构和专业团体合作，确保这项研究切合实际和适当。通过与这些团体合作，我们还将确保SMART健康糖尿病如果被证明是有效和安全的，可以在常规糖尿病护理中得到更广泛的应用。

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.