Making INformed Decisions in Gaze and Postural Stability (MINDGAPS): a Novel System for Improving Personalized Care and Patient Adherence in Vestibular Rehabilitation

在凝视和姿势稳定性 (MINDGAPS) 方面做出明智的决策：一种用于改善前庭康复中的个性化护理和患者依从性的新系统

• 批准号: 10610466
• 负责人: Brian James Loyd
• 金额: $ 19.06万
• 依托单位: UNIVERSITY OF MONTANA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10610466
• 关键词: Address; Adherence; Adverse event; Age; Aged, 80 and over; Area; Behavioral; Behavioral Sciences; Blurred vision; Cardiovascular Diseases; Caring; Clinical; Clinical Practice Guideline; Clinical Trials; Communities; Controlled Clinical Trials; Data; Development; Devices; Disease; Dizziness; Dose; Effectiveness; Elderly; Eligibility Determination; Equilibrium; Exercise; Feedback; Future; General Population; Head; Health; Individual; Intervention; Interview; Intuition; Investigation; Link; Measurement; Measures; Methods; Monitor; Musculoskeletal Equilibrium; National Institute on Deafness and Other Communication Disorders; Osteoporosis; Outcome; Participant; Patient Monitoring; Patient Recruitments; Patient Self-Report; Patients; Persons; Phase; Phase II Clinical Trials; Posture; Preparation; Publishing; Recommendation; Rehabilitation therapy; Reporting; Research; Research Personnel; Safety; Science; Social isolation; Structure; Symptoms; System; Technology Assessment; Testing; Time; Treatment Efficacy; United States National Aeronautics and Space Administration; United States National Institutes of Health; Visual Acuity; Work; adherence rate; age related; cohort; comparison control; compliance behavior; computerized; design; exercise program; exercise regimen; experience; fall risk; falls; gaze; improved; indexing; innovation; instrument; novel; peer; personalized care; poor health outcome; primary outcome; recruit; remediation; remote monitoring; remote patient monitoring; remote sensing; retention rate; routine practice; safety and feasibility; safety assessment; sarcopenia; secondary outcome; sedentary lifestyle; social norm; telehealth; treatment response; usability; vestibulo-ocular reflex; wearable sensor technology; web app

PROJECT SUMMARY/ABSTRACT Deficits in gaze and postural stability are closely linked with vestibular hypofunction. These deficits result in dizziness and poor balance, increasing the risk for falls and other poor health outcomes. Vestibular hypofunction occurs with several conditions and is increasingly prevelant with advancing age. An estimated 85% of people over the age of 80 experience vestibular hypofunction. As with many age-related health challenges (e.g. sarcopenia, osteoporosis, cardiovascular disease), exercise is widely recommended to remediate the effects of vestibular hypofunction. Vestibular rehabilitation has demonstrated efficacy at improving vestibular hypofunction in tightly controlled clinical trials, but the effectiveness in practice is limited by two major barriers: 1) reduced patient adherence to the exercise program, and 2) inability to precisely assess vestibular function. These are overlapping challenges; lack of access to vestibular function assessments impedes effective dosing of rehabilitation as well as monitoring of patient adherence and progress. Thus, personalization and monitoring—essential ingredients of nearly any health or exercise regimen—are functionally missing in vestibular rehabilitation practice. For this proposal, we have developed the Making INformed Decisions in Gaze and Postural Stability (MINDGAPS) system, which utilizes wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises. Additionally, MINDGAPS leverages NIH Toolbox data to display patient status compared to normative values and to indicate progress over time relative to measurement error. This enables the application of two innovative behavioral science principles aimed at facilitating patient adherence: 1) social norming; comparison of a patient to her or his peers, and 2) frequent monitoring of progress and outcomes. This study is designed to examine the preliminary efficacy of the MINDGAPS system, along with the feasibility, safety, and acceptability of its use in practice. We will use a single cohort, double-basline design (n=30 older adults with vestibular hypofunction). Following, the baseline (control) phase, all participants will complete 6 weeks of individualized vestibular rehabilitation informed by the MINDGAPS system. Preliminary efficacy of the intervention will be examined by comparing computerized Dynamic Visual Acuity (cDVA) scores during the intervention phase to cDVA scores during the baseline phase. Other clinical outcomes (e.g., postural stability, video-head impulse testing, patient reported dizziness) will also be examined. Feasibility and safety of the intervention will be examined relative to a priori thresholds for recruitment, retention and adherence rates, as well as recording of adverse events. Finally, the acceptability and remote/telehealth capability of the system will be explored using a mixed methods analysis, which will inform system refinement in preparation for a future R01 submission (phase II clinical trial).

项目摘要/摘要 凝视和姿势稳定性的缺陷与前庭功能障碍密切相关。这些定义结果 头晕和平衡不佳，增加了跌倒和其他健康状况不佳的风险。前庭 功能障碍在几种情况下发生，并且随着年龄的增长而越来越多。估计 80岁以上的人中，有85％的人经历了前庭功能障碍。与许多与年龄有关的健康 挑战（例如肌肉减少症，骨质疏松症，心血管疾病），广泛建议进行运动 修复前庭功能障碍的影响。前庭康复表现出效率 在严格控制的临床试验中改善前庭功能低下，但实践中的有效性有限 通过两个主要障碍：1）降低患者对运动计划的依从性，2）无法精确 评估前庭功能。这些是重叠的挑战；缺乏前庭功能 评估阻碍了有效的康复剂量以及监测患者依从性和 进步。那是个性化和监测 - 几乎任何健康或运动的本质成分 方案 - 前庭康复实践中缺少功能。 对于此提案，我们制定了凝视和姿势稳定的明智明智决定 （MindGaps）系统，该系统利用可穿戴传感器技术提供简单的精确度量 和姿势稳定性，以及对患者遵守前庭运动的远程监控。此外， Mindgaps利用NIH工具箱数据显示与正常值相比 指出相对于测量误差的随时间的进步。这可以应用两个创新 旨在促进患者依从性的行为科学原则：1）社会规范；比较患者 对她或他的同龄人，以及2）经常监视进度和结果。这项研究旨在检查 思维胶质系统的初步效率，以及其使用的可行性，安全性和可接受性 实践。我们将使用单个队列，双层式设计（n = 30个具有前庭功能障碍的老年人）。 随后，基线（对照）阶段，所有参与者将完成6周的个性化前庭 康复由思维群落系统告知。干预的初步效率将由 在干预阶段比较计算机化的动态视力（CDVA）分数与CDVA评分 在基线阶段。其他临床结果（例如，姿势稳定性，视频脉冲测试，患者 报告头晕）也将被检查。将检查干预的可行性和安全性 招聘，保留率和依从率以及不良事件记录的先验阈值。 最后，将使用混合方法探索系统的可接受性和远程/远程医疗功能 分析，这将为您的系统改进提供信息，以准备未来的R01提交（II期临床试验）。