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 型糖尿病的一种破坏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），许多地区的糖尿病护理仍然有限，包括并发症的管理。糖尿病足溃疡（DFU）可以通过筛查来预防，特别是在高危人群中，通过积极参与足部监测行为来预防。拟议的研究项目将在秘鲁卡耶塔诺埃雷迪亚大学（秘鲁）与多家机构和研究机构合作进行。将开发并测试一种预防糖尿病足溃疡（DFU）的创新方法。该项目有三个工作包（WP）。在 WP1 中，该研究将 1) 开发一种人工智能 (AI) 算法，该算法将使用足部自拍照图像识别溃疡发作之前的迹象，2) 共同设计用于预防 DFU 的足部自拍照 mHealth 工具，以及 3) 试点测试足部自拍 mHealth 工具，以评估 AI 算法的可用性和准确性。在 WP2 中，该研究将评估足部自拍和足部测温是否比加强常规护理更有效预防 DFU，以及足部自拍是否不劣于足部测温。 WP3 的重点是利益相关者的参与和实施，并贯穿项目的整个持续时间，以探索如何在秘鲁卫生系统中实施这些干预措施。 WP3 包括详细的过程评估，以了解复杂的干预措施（足部自拍和足部测温）对谁有效，以及在整个项目中如何以及为何有效。此外，经济评估将评估干预措施的成本效益。该项目还致力于建设个人和机构能力。首先，加强社区研究参与，邀请患者组织的代表参加董事会并参加定期项目会议。其次，积极参与更广泛的研究合作伙伴网络的能力建设，例如患者及其家人、倡导组织和政策制定者，以加强将“活生生的”证据纳入研究，并增加纳入政策的潜力。我们的提案包含了中低收入国家非常需要的多项务实创新。这种家用、易于使用、低成本的 mHealth 足部自拍工具可促进足部自我监测的习惯，并可通过量身定制的指导和对关注的特征进行早期分类，有助于 DFU 的一级预防。随着时间的推移拍摄的脚部照片记录可以提供客观的评估，可供医疗保健提供者前瞻性地使用。远程医疗解决了提供面对面长期护理的局限性，这种局限性在 COVID-19 大流行期间变得更加严重。使用溃疡前阶段的图像来制定预防 DFU 的策略是新颖的，并且之前尚未研究过使用人工智能来预防 DFU。最后，通过三组非劣效性设计在中低收入国家环境中测试两种干预措施是一种使用多功能试验平台的稳健方法。该项目的研究结果旨在克服中低收入国家提供慢性护理的局限性和短缺糖尿病和 DFU 专家。该项目的社会影响依赖于中断或避免足部溃疡和截肢的路径，从而提高糖尿病患者的生活质量。