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

一项针对泰国农村地区 2 型糖尿病检测和管理的创新、低成本初级保健计划的整群随机试验

• 批准号: MR/R02040X/2
• 负责人: Vivek Jha
• 金额: $ 35.82万
• 依托单位: Imperial College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FR02040X%2F2
• 关键词: cluster; randomised; trial; innovative; low

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.

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。据估计，2013年有3.2名泰国成年人（占成年人口的6.4%）患有糖尿病，预计到2035年将增长到520万。通过透析治疗晚期肾衰竭是昂贵的，2011年花费泰国医疗保健预算的约3.6%，预计到2018年将增加到6.2%。如果早期发现，这种并发症大多数可以预防。尽管泰国实施了全民健康覆盖，但卫生保健系统-特别是为农村人口服务的系统-仍然缺乏管理糖尿病的能力，因为医生短缺，而且很少有组织的糖尿病方案。这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检测和管理糖尿病的替代方法。一个潜在的方法是使用更广泛的卫生保健工作人员，如村卫生工作者。这些工作人员没有医学资格，但接受过卫生培训，有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“智能健康”的战略，根据最佳实践，使用非医生的医疗保健工作者来识别和管理患有糖尿病和肾脏疾病的村民。医护人员将接受培训，学会使用一种简单的移动终端（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，并立即获得有关如何使用药物治疗患者的建议和/或由电子程序生成的生活方式建议。该计划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。该计划还与患者的个人健康记录相关联，以便他们可以进行随访或酌情转诊至医院。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测量SMART健康糖尿病的有效性，该试验比较了20个接受过使用SMART健康糖尿病培训的村庄（“干预”村庄）和20个没有SMART健康糖尿病但将继续其常规做法的村庄（“对照”村庄）。然后，我们将比较来自干预和村庄的个体在重要的糖尿病相关结果方面的差异，如血糖控制和肾损伤。与此同时，我们将进行经济评估，并与卫生工作者进行访谈，以确定SMART健康糖尿病是否具有成本效益和可接受。我们将与乡村领导人，政府组织和专业团体合作，以确保研究是相关的和适当的。通过与这些团体合作，我们还将确保SMART Health Diabetes在被证明有效和安全的情况下，可以更广泛地用于常规糖尿病护理。

项目成果

PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V).

• DOI: 10.1186/s13063-023-07128-z
• 发表时间: 2023-03-13
• 期刊: Trials
• 影响因子: 2.5