Investigating and implementing scalable interventions to prevent diabetic foot ulcers

研究和实施可扩展的干预措施以预防糖尿病足溃疡

• 批准号: MR/X004163/1
• 负责人: Maria Lazo-Porras
• 金额: $ 138.2万
• 依托单位: Cayetano Heredia University
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FX004163%2F1
• 关键词: Investigating; implementing; scalable; interventions; prevent

Lower limb amputation is a devastating and preventable complication of type 2 diabetes. As the burden of diabetes rises, particularly in low- and middle-income countries (LMICs), diabetes care remains limited in many settings, including the management of complications. Diabetic foot ulcers (DFU) can be prevented with screening, particularly in high-risk individuals, by actively engaging them in foot monitoring behaviours.The proposed research project will take place at the Universidad Peruana Cayetano Heredia (Peru) in collaboration with several institutions and will develop and test an innovative approach for the prevention of diabetic foot ulcers (DFU). The project has three work packages (WP). In WP1, the study will 1) develop an artificial intelligence (AI) algorithm that will identify signs prior to ulcer onset using foot selfie images, 2) co-design a foot selfie mHealth tool for the prevention of DFU, and 3) pilot-test the foot selfie mHealth tool to assess usability and accuracy of the AI algorithm. In WP2, the study will assess whether foot selfie and foot thermometry are more effective than enhanced usual care in preventing DFU and whether the foot selfie is non-inferior to foot thermometry. WP3 is focused on engagement with stakeholders and implementation and runs across the entire duration of the project to explore how these interventions can be implemented in the Peruvian health system. WP3 includes a detailed process evaluation to understand for whom the complex interventions (foot selfie and foot thermometry) worked for, as well as how and why, throughout this project. In addition, the economic evaluation will assess the cost-effectiveness of the interventions. The project is also committed to building individual and institutional capacity. First, enhancing community research engagement, bringing representatives from patient organisations to sit on the board and attend regular project meetings. Second, actively engaging in building the capacity of our wider network of research partners, such as patients and their families, advocacy organisations, and policymakers to enhance the incorporation of 'lived' evidence into research and increase the potential for uptake into policy. Our proposal encompasses several pragmatic innovations, much needed in LMIC settings. This home-based, easy-to-use, low-cost mHealth foot selfie tool promotes the habit of foot self-monitoring and can contribute to the primary prevention of DFU through tailored guidance and early triage of features of concern. The photographic documentation of the feet captured over time can provide objective assessments that can be used prospectively by healthcare providers. Telemedicine addresses the limitations in the provision of in-person chronic care, which have been exacerbated during the COVID-19 pandemic. The use of images at the pre-ulcer stage to develop a strategy for the prevention of DFU is novel and the use of AI in the prevention of DFU has not been previously studied. Finally, testing two interventions in an LMIC setting with a three-arm non-inferiority design is a robust methodological approach that uses a versatile trial platform.The findings from this project are oriented to overcome the limitations in providing chronic care in LMICs and the shortage of diabetes and DFU specialists. The social impact of the project relies on the interruption or avoidance of the path towards foot ulcers and amputation, thus improving the quality of life of people living with diabetes.

下肢截肢是2型糖尿病的毁灭性且可预防的并发症。随着糖尿病负担的增加，特别是在低收入和中等收入国家（LMIC）的负担，糖尿病护理在许多情况下仍然有限，包括并发症的管理。糖尿病足溃疡（DFU）可以通过筛查，尤其是在高风险个人中，通过积极参与足部监控行为来预防。拟议的研究项目将在Peruana Cayetano Heredia大学（Peruana Cayetano Heredia大学（秘鲁）大学）与多个机构合作，并将与多个机构合作，并将开发和测试一种创新的糖尿病脚踏型脚步（DFU）（DFU）（DFU）（DFU）。该项目有三个工作包（WP）。在WP1中，研究将1）开发一种人工智能（AI）算法，该算法将使用脚自拍照图像在溃疡发作之前识别符号，2）共同设计一种预防DFU的脚自拍照工具，3）PILOT检验，以评估AI Algorithm的脚自拍照工具以评估AI Algorithm的可用性和准确性。在WP2中，该研究将评估脚自拍照和脚体温测定法在防止DFU以及脚自拍照中是否不属于脚部温度法更有效。 WP3专注于与利益相关者和实施的交往，并在项目的整个过程中运行，以探讨如何在秘鲁卫生系统中实施这些干预措施。 WP3包括一个详细的过程评估，以了解复杂的干预措施（自拍照和脚部温度计）的工作，以及整个项目中如何和原因。此外，经济评估将评估干预措施的成本效益。该项目还致力于建立个人和机构能力。首先，加强社区研究的参与度，使患者组织的代表坐在董事会上并参加定期的项目会议。其次，积极参与建立我们更广泛的研究伙伴网络的能力，例如患者及其家人，倡导组织和决策者，以增强“生活”证据的纳入研究，并提高对政策的吸收潜力。我们的建议涵盖了几项实用创新，在LMIC环境中急需。这款基于家庭的，易于使用的低成本MHealth脚自拍照工具可促进脚步自我监控的习惯，并通过量身定制的指导和早期的关注特征来为DFU的主要预防做出贡献。随着时间的推移，捕获的脚的摄影文档可以提供客观评估，医疗保健提供者可以前瞻性地使用。远程医疗解决了亲自慢性护理的局限性，这些慢性护理在COVID-19-19大流行期间已加剧。在前粉末阶段使用图像来制定预防DFU的策略是新颖的，并且以前尚未研究过AI在预防DFU中的使用。最后，使用三臂非效率设计在LMIC环境中测试两种干预措施是一种使用多功能试验平台的强大方法论方法。该项目的发现是为了克服LMICS和糖尿病和DFU专家的长期护理的局限性。该项目的社会影响依赖于打扰或避免脚步溃疡和截肢的道路，从而改善了糖尿病患者的生活质量。