Feasibility and effectiveness of a pilot remote monitoring program for the treatment of diabetic foot ulcers

糖尿病足溃疡治疗远程监测试点计划的可行性和有效性

• 批准号: 10509442
• 负责人: Caitlin Whitney Hicks
• 金额: $ 9.45万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-10 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10509442
• 关键词: Adult; Affect; Amputation; Award; Black race; Caregivers; Caring; Client satisfaction; Clinic; Clinic Visits; Clinical Management; Clinical Trials; Computers; Data; Diabetes Mellitus; Diabetic Foot Ulcer; Disadvantaged; Effectiveness; Enrollment; Epidemic; Evaluation; Goals; Grant; Health Care Visit; Image; K-Series Research Career Programs; Lower Extremity; Mentors; Modeling; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Operative Surgical Procedures; Outcome; Participant; Patients; Peripheral Nervous System Diseases; Persons; Proteomics; Provider; Race; Randomized; Randomized Clinical Trials; Recommendation; Research; Research Personnel; Research Proposals; Risk; Risk Factors; Scanning; Schedule; Socioeconomic Status; Surveillance Program; Surveys; Technology; Time; Transportation; Treatment outcome; Universities; Vulnerable Populations; Work; arm; barrier to care; base; cost; diabetic; feasibility trial; follow-up; foot; healing; high risk; improved; low socioeconomic status; medical schools; mid-career faculty; multidisciplinary; new technology; novel; patient engagement; patient oriented; programs; racial disparity; remote monitoring; satisfaction; smartphone Application; socioeconomic disadvantage; socioeconomic disparity; standard of care; treatment disparity; treatment program; usability; wound; wound care; wound healing

PROJECT SUMMARY/ABSTRACT Caitlin W. Hicks MD, MS is an Associate Professor of Surgery in the Department of Surgery at Johns Hopkins University School of Medicine. She currently holds a K23 Mentored Career Development Award from the NIDDK focused on the risk factors, outcomes, and proteomics of diabetic peripheral neuropathy. She seeks an R03 award to expand her research focus to a clinical trial that will inform her research and clinical management of adults with diabetes and lower extremity complications. Dr. Hicks’ research proposal details a pilot randomized controlled feasibility trial of a novel remote wound monitoring program for the treatment of diabetic foot ulcers (DFUs). The specific aims of the research agenda are to 1) Establish the feasibility of a novel remote patient-centered monitoring program for the surveillance and monitoring of DFUs; 2) Assess patient and provider satisfaction with remote DFU monitoring technology compared to standard in-person monitoring; and 3) Generate pilot data on wound healing time and major amputation risk in patients with DFU who are monitored remotely compared to DFU patients treated with standard of care. One-hundred and twenty patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks. Patients enrolled in the remote wound monitoring technology arm will upload weekly wound photos using a smartphone application to a dedicated portal where the care team can monitor the wound progression over time, and attend scheduled in-person follow-up at enrollment, week 4, week 8, and week 12. Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for an in- person wound assessment. Outcomes will include technology feasibility (defined as the number of participants who successfully complete at least one remote wound scan per week); patient engagement and app usability, patient satisfaction, and provider satisfaction (based discrete and open-ended survey questions at study completion); and wound size reduction at 12 weeks (%), wound healing time (days), and major amputation. This study will provide actionable data about the feasibility of using remote DFU monitoring technology in disadvantaged patients, possibly improving patient satisfaction and wound healing outcomes compared to standard in-person monitoring. The results will provide preliminary data to support a R01 grant submission that will rigorously evaluate this technology in the setting of a large randomized clinical trial. By providing pilot and feasibility data to help support a subsequent R01, this R03 proposal will enhance the capability of Dr. Hicks to transition to an independent investigator.

项目摘要/摘要 凯特琳·W·希克斯，医学博士，约翰霍普金斯大学外科副教授 大学医学院。她目前持有K23指导职业发展奖 NIDDK专注于糖尿病周围神经病变的危险因素、结果和蛋白质组学。她在寻找一个 R03奖，将她的研究重点扩大到一项临床试验，这将为她的研究和临床管理提供信息 患有糖尿病和下肢并发症的成年人。希克斯博士的研究提案详细说明了一项试验 一种新的远程伤口监测方案治疗糖尿病的随机对照可行性试验 足部溃疡(DFU)。研究议程的具体目的是：1)确定小说的可行性 远程以患者为中心的监测计划，用于监测和监测DFU；2)评估患者 与标准的面对面监控相比，提供商对远程DFU监控技术的满意度； 以及3)生成关于伤口愈合时间和DFU患者的主要截肢风险的试点数据 与接受标准护理治疗的DFU患者相比，远程监测。120名患者 将采用计算机随机1：1方式，使用远程DFU监控技术或 为期12周的标准面对面监控。参加远程伤口监测技术ARM的患者 将使用智能手机应用程序每周将伤口照片上传到护理团队所在的专用门户 可以监控伤口随时间的进展，并在注册时参加预定的面对面随访，第4周， 第8周和第12周。随机选择接受标准护理的患者将获得伤口护理计划 在登记时，然后每两周(第2、4、6、8、10、12周)在诊所随访一次- 人身伤情评估。成果将包括技术可行性(定义为参与者的数量 每周至少成功完成一次远程伤口扫描)；患者参与度和应用程序可用性， 患者满意度和提供者满意度(基于研究中的离散和开放式调查问题 12周时伤口缩小(%)、伤口愈合时间(天)和主要截肢。 这项研究将为在中国使用远程DFU监控技术的可行性提供可操作的数据 弱势患者，可能会提高患者满意度和伤口愈合结果 标准的面对面监控。结果将提供初步数据，以支持R01拨款申请 将在一项大型随机临床试验的背景下严格评估这项技术。通过提供试点和 可行性数据，以帮助支持后续的R01，此R03提案将增强希克斯博士的能力 过渡到一个独立的调查员。