Implementation of foot thermometry and SMS to prevent diabetic foot ulcer

实施足部测温和短信预防糖尿病足溃疡

• 批准号: 8807993
• 负责人: J Jaime Miranda
• 金额: $ 19.07万
• 依托单位: UNIVERSIDAD PERUANA CAYETANO HEREDIA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8807993
• 关键词: African; Amputation; Books; Caring; Cellular Phone; Clinical; Clinical Research; Clinical Trials; Complications of Diabetes Mellitus; Cost Effectiveness Analysis; Country; Data; Developed Countries; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Diagnosis; Diagnostic; Disease; Early Diagnosis; Early Intervention; Education; Enrollment; Esthesia; Evaluation; Family; Foot Ulcer; Gold; Health; Home environment; Incidence; Income; Instruction; Intervention; Life; Literature; Measurement; Measures; Medical; Methods; Modality; Monitor; Morbidity - disease rate; Neural Conduction; Neuropathy; Outcome; Patients; Peripheral Nervous System Diseases; Peru; Prevalence; Public Hospitals; Resources; Risk; Science; Self Management; Services; Skin; Societies; South America; Technology; Temperature; Text; Thermometers; Thermometry; Time; Training; Translating; Ulcer; United States National Institutes of Health; Work; arm; base; compliance behavior; cost; cost effective; cost effectiveness; diabetes control; diabetic; diabetic patient; diagnosis standard; economic cost; foot; high risk; implementation science; improved; mHealth; novel; prevent; prognostic; public health relevance; response; rural area; screening; social; standard of care; urban area

DESCRIPTION (provided by applicant): This application is in response to the GACD solicitation of applications (NOT-TW-14-003) in response to the existing trans-NIH Initiative on Dissemination and Implementation Science (PAR-13-054). There are an estimated 285 million people worldwide living with diabetes, 70% of whom are in low and middle- income countries (LMIC). Underdiagnoses of diabetes is particularly significant in LMIC, where less than 50% of diabetics are diagnosed. When diagnosis does not occur before the onset of clinical manifestations of the disease, complications and morbidity rise exponentially. Therefore, one of the major challenges in diabetes control in these limited resource settings is the need for a resource-appropriate, rapid screening method to identify diabetics and treat them early enough to delay the onset of complications. Diabetic Foot Neuropathy (DFN) is one of the most important complications and is one of the most significant prognostics for foot amputation. Early diagnosis and intervention can prevent foot ulcers and amputation, minimizing the social and economic costs of diabetes. The gold standard for diagnosis of DFN is a nerve conduction study, but unfortunately this is very costly and time consuming. Therefore, this is not an appropriate technology for LMIC settings, and a simple and inexpensive monitoring method is needed. Thermometry measures local skin warmth and is one of the more promising emerging modalities for the evaluation of DFU. However, patient compliance with at-home monitoring is a concern, as they may be forgetful or find it difficult to get into a consistent routine of daily monitoring. Therefore, we propose to determine the utility of SMS messaging to remind the patients to perform the thermometry, and to assess the impact on outcome. We will enroll diabetic subjects with neuropathy at risk for ulceration into a clinical study with two arms: both arms will receive education about DFU at the beginning of the study, and will be provided with a foot thermometer and instructions on its use. They will be asked to record multiple foot temperature measurements on a daily basis. However, one arm will also receive text messages reminding them to use the thermometer, while the other arm will not. With this study, we will perform the following specific aims: Specific Aim 1. Compare the incidence of DFU during the study between the two arms. We hypothesize that subjects who receive SMS will have a lower incidence of DFU than the subjects who do not receive SMS. Specific Aim 2. Compare compliance with foot thermometer use between the two arms. We hypothesize that subjects who receive SMS will be more compliant with temperature measurement.

描述（由申请人提供）：本申请是对GACD申请征集（NOT-TW-14-003）的回应，以回应现有的跨NIH传播和实施科学倡议（PAR-13-054）。据估计，全世界有2.85亿人患有糖尿病，其中70%在低收入和中等收入国家（LMIC）。糖尿病的诊断不足在LMIC中尤其显著，其中不到50%的糖尿病患者被诊断出来。如果在疾病的临床表现出现之前没有得到诊断，并发症和发病率就会呈指数上升。因此，在这些资源有限的环境中，糖尿病控制的主要挑战之一是需要一种资源适当的快速筛查方法来识别糖尿病患者并及早治疗以延迟并发症的发生。糖尿病足神经病变（DFN）是糖尿病足最重要的并发症之一，也是足截肢最重要的原因之一。早期诊断和干预可以预防足部溃疡和截肢，最大限度地减少糖尿病的社会和经济成本。诊断DFN的金标准是神经传导研究，但不幸的是，这是非常昂贵和耗时的。因此，这不是用于LMIC设置的适当技术，并且需要简单且廉价的监测方法。测温法测量局部皮肤温度，是评估DFU的最有前途的新兴方法之一。然而，患者对家庭监测的依从性是一个问题，因为他们可能健忘或发现难以进入日常监测的一致例程。因此，我们建议确定短信提醒患者进行体温测量的效用，并评估对结果的影响。我们将入组具有溃疡风险的神经病变的糖尿病受试者进入一项临床研究，分为两组：两组将在研究开始时接受关于DFU的教育，并将提供足部温度计及其使用说明。他们将被要求每天记录多个足部温度测量值。但是，一只手臂也会收到短信，提醒他们使用温度计，而另一只手臂不会。通过这项研究，我们将实现以下具体目标：具体目标1。比较两组研究期间DFU的发生率。我们假设接受SMS的受试者的DFU发生率低于未接受SMS的受试者。具体目标2。比较两个手臂之间使用足部温度计的依从性。我们假设接受SMS的受试者将更符合温度测量。