Physical Activity Interventions for Leg Ulcer Patients

腿部溃疡患者的身体活动干预措施

• 批准号: 9070782
• 负责人: Teresa J Kelechi
• 金额: $ 18.34万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-19 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9070782
• 关键词: Accelerometer; Activities of Daily Living; Adherence; Adopted; Adoption; Amputation; Ankle; Articular Range of Motion; Behavior; Blood Circulation; Caring; Cellular Phone; Chronic Disease; Chronically Ill; Clinical; Communication; Comorbidity; Data; Development; Devices; Diabetes Mellitus; Distress; Electronic Mail; Energy Metabolism; Enrollment; Evaluation; Feasibility Studies; Feedback; Foot Pain; Frequencies; Future; Goals; Healed; Health Personnel; Health Technology; Home environment; Human Resources; Individual; Instruction; Internet; Intervention; Leg; Leg Ulcer; Link; Lower Extremity; Measurement; Measures; Monitor; Motion; Movement; Nature; Notification; Outcome; Pain; Patient-Centered Care; Patients; Phase; Physical activity; Physicians; Population; Procedures; Process; Provider; Randomized; Recommendation; Reporting; Resources; Sample Size; Self Management; Services; Signal Transduction; Stress; Symptoms; System; Technology; Testing; Text; Time; Toes; Training; Ulcer; Varicose Ulcer; Venous; Walking; Wireless Technology; Work; base; comparative; compliance behavior; conditioning; cost; cost effectiveness; deconditioning; design; evidence base; fitbit; fitness; foot; functional outcomes; healing; healthy lifestyle; improved functioning; innovation; mHealth; novel; patient oriented; pilot trial; programs; public health relevance; theories; therapy design; usability; wound

 DESCRIPTION (provided by applicant): Mobile Health (mHealth) technology can help individuals adopt healthy lifestyle behaviors, particularly in physical activity (PA) for the treatment and self-management of chronic diseases. As patient centered care melds with emerging patient centered technology, a need exists to promote effective patient-provider communication. This is especially important for minimally ambulatory, chronically ill populations. We propose FOOTFIT, a novel lower leg conditioning mHealth intervention for patients with venous leg ulcers. We aim to compare two versions, one of which is enhanced (FOOTFIT+), to determine which has the greatest impact on PA adherence, patient-provider communication, and leg function. FOOTFIT and FOOTFIT+ share three components: 1) a low-cost, tri-axial Bluetooth(r) enabled highly sensitive accelerometer and tracking device (BEAT) worn on the foot during, 2) phased conditioning activities for lower leg function (CALF) tracked by a, 3) Smartphone that captures signals from BEAT, provides motivational messages, CALF instruction, and automated feedback on progress. FOOTFIT+ has the added component that promotes patient-provider communication through Internet connectivity via the Smartphone. We designed this PA intervention as an initial step in conditioning severely deconditioned lower legs of minimally ambulatory patients who have limited access to PA programs. To our knowledge, a system that connects accelerometers and patient-provider communication to examine adherence to PA in leg ulcer populations has not been tested. Two important features of this intervention are worth noting. First, foot-based accelerometry (e.g. Fitbit(r)) is well documented for the capture of activity and energy expenditure in mobile, healthier populations. Developed and tested by our study team, our valid and reliable foot-based BEAT emphasizes the capture of less intense activity (e.g. toe and foot movements) that is often the maximum intensities displayed by these deconditioned patients who can at best only take a few steps at a time. Secondly, the study will test the feasibility and acceptability of having a patient-provider communication link as part of FOOTFIT+. These patients will have access to the provider via the Smartphone (email, text, direct calling), and will receive automated and personalized, motivational messages and theory-based verbal exchanges from the provider. We seek to discover whether patients with leg ulcers use the FOOTFIT system as recommended and if it increases adherence to PA, promotes communication between patients and providers, reduces physically distressing symptoms, and enhances lower extremity functional abilities. We believe FOOTFIT+ will facilitate more timely and effective patient-provider communication around feedback on patient progress. We will evaluate how this will work in the real world with the strain that it might place on busy providers. Forty patients will be targeted in this six-week study, 20 o which will receive FOOTFIT and 20 FOOTFIT+.

 描述（由申请人提供）：移动健康（mHealth）技术可以帮助个人采取健康的生活方式行为，特别是在用于治疗和自我管理慢性病的体育活动（PA）方面。随着以患者为中心的护理与新兴的以患者为中心的技术相结合，需要促进有效的患者与提供者的沟通。这对于很少行走的慢性病人群尤其重要。我们提出了 FOOTFIT，这是一种针对腿部静脉溃疡患者的新型小腿调理 mHealth 干预措施。我们的目标是比较两个版本，其中之一是增强版 (FOOTFIT+)，以确定哪个版本对 PA 依从性、医患沟通和腿部功能影响最大。 FOOTFIT 和 FOOTFIT+ 共有三个组件：1) 低成本、三轴蓝牙 (r) 支持的高灵敏度加速计和跟踪设备 (BEAT)，在进行期间佩戴在脚上，2) 跟踪小腿功能 (CALF) 的分阶段调节活动，3) 智能手机，捕获来自 BEAT 的信号，提供激励信息、CALF 指令和自动进度反馈。 FOOTFIT+ 增加了一个组件，可通过智能手机的互联网连接促进患者与提供者之间的沟通。我们将这种 PA 干预设计为第一步，旨在对那些无法充分活动、无法参与 PA 项目的患者进行小腿严重损伤的调理。据我们所知，连接加速度计和医患沟通以检查腿部溃疡人群对 PA 依从性的系统尚未经过测试。此次干预有两个重要特征值得注意。首先，基于足部的加速度测量（例如 Fitbit(r)）已被充分记录用于捕获移动、健康人群的活动和能量消耗。我们的有效且可靠的基于足部的 BEAT 由我们的研究团队开发和测试，强调捕捉不太剧烈的活动（例如脚趾和足部运动），这通常是这些身体状况不佳的患者所表现出的最大强度，他们一次最多只能走几步。其次，该研究将测试将患者与提供者之间的通信链路作为 FOOTFIT+ 一部分的可行性和可接受性。这些患者将可以通过智能手机（电子邮件、短信、直接呼叫）联系医疗服务提供者，并从医疗服务提供者那里接收自动的、个性化的、激励性的信息和基于理论的口头交流。我们试图了解腿部溃疡患者是否按照建议使用 FOOTFIT 系统，以及它是否可以提高 PA 的依从性、促进患者与提供者之间的沟通、减少身体不适症状并增强下肢功能能力。我们相信 FOOTFIT+ 将促进患者与提供者围绕患者进展反馈进行更及时、有效的沟通。我们将评估这在现实世界中如何发挥作用 它可能会给繁忙的提供商造成压力。这项为期六周的研究将针对 40 名患者，其中 20 名患者将接受 FOOTFIT 治疗，20 名患者将接受 FOOTFIT+ 治疗。