Physical Telerahabilitation in Veterans with Multiple Sclerosis

患有多发性硬化症的退伍军人的身体远程康复

• 批准号: 8499086
• 负责人: WALTER ROYAL
• 金额: --
• 依托单位: BALTIMORE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8499086
• 关键词: Behavioral; Blinded; Caring; Chronic; Chronic Disease; Clinical; Clinical Trials Design; Communication; Communities; Computers; Control Groups; Data; Disabled Persons; Disease; Education; Enrollment; Equilibrium; Evaluation; Exercise; Fatigue; Funding; Gender; Healthcare; Healthcare Systems; Home environment; Impairment; Improve Access; Internet; Intervention; Knowledge; Life; Mediating; Medical; Medical Informatics; Mental Depression; Modeling; Monitor; Multiple Sclerosis; Nervous system structure; Nurse Practitioners; Outcome; Outcome Study; Patients; Physical Rehabilitation; Physical therapy; Pilot Projects; Policies; Process; Provider; Quality of Care; Quality of life; Race; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Recruitment Activity; Rehabilitation Outcome; Rehabilitation therapy; Reporting; Research; Resources; Sample Size; Sampling; Self Efficacy; Social support; Specialist; Subgroup; Symptoms; System; Technology; Telecommunications; Telemedicine; Testing; Time; Training; Update; Veterans; Walking; base; chronic care model; compliance behavior; depressive symptoms; design; disability; evidence based guidelines; experience; foot; functional outcomes; functional status; group intervention; handbook; improved; innovation; nervous system disorder; peer; primary outcome; programs; psychosocial; rehabilitation service; satisfaction; secondary outcome; telehealth; telerehabilitation

DESCRIPTION (provided by applicant): The objective of the proposed research is to establish the clinical value of a home-based physical telerehabilitation model in veteranswith debilitating nervous system conditions such as multiple sclerosis (MS), and to provide evidence-based recommendations on the use of this technology for care coordination. The primary aim of this study is to determine the effect of home-based physical telerehabilitation on functional outcomes in veterans with MS in a 6 month randomized controlled trial. The primary hypothesis is: Physical telerehabilitation will result in 15% improvement of the Berg Balance Scale Score and a 3-second reduction of timed 25-Foot Walk at 6 months as compared to a control group. Secondary aims of the project include examining the effect of physical telerehabilitation on symptom activity, and behavioral-psychosocial outcomes at 6 months. This study will utilize a permuted block randomization design to compare the effect of home physical telerehabilitation (intervention) with routine rehabilitation care (control) in veterans with MS. Based on a power analysis utilizing data from our pilot study, the required total sample size is 108. A sample of eligible veterans with MS will be recruited within VISN 5 and randomized to the intervention and control groups. Randomization into these groups will also be stratified by two Expanded Disability Status Scale groups (EDSS 2.0-4.0 and EDSS 4.5-6.5). Patients enrolled to the intervention group will receive a Home Automated Telemedicine (HAT) system that will be installed at the patient's home by a research assistant. Both intervention and control groups will receive an individualized physical therapy plan for the 6-month study period and will be trained on how to perform the exercise program. After a baseline evaluation, the patients in the intervention group will receive computer-mediated support in following their individualized exercise plans via HAT at their homes on a daily basis. Study outcome evaluations will be performed at 3 months and 6 months by a blinded clinical team consisting of a physical therapist and a nurse practitioner. The clinical impact of telerehabilitation will be estimated in three major domains: functional status, symptom activity, and the behavioral and psychosocial domain. The primary outcome will be the difference between groups in scores assessing patient functional status by the timed 25-foot walk and the Berg Balance Scale. The functional status will also be assessed using the 6-minute walk, MS Walking Scale, the MS Functional Composite, and the EDSS. Symptom activitywill be a secondary outcome estimated using the Modified Fatigue Impact Scale and the MS Impact Scale. Other secondary outcomes from behavioral and psychosocial domain will include the MS Self-efficacy scale, depression symptoms, and disease-specific quality of life. The results of this study will provide important information on the use of modern telecommunication technologies to improve care in veterans with debilitating chronic neurological disorders. Distance, disability and lack of appropriate specialists often limit access to rehabilitation services within the VA health care system, and the proposed telerehabilitation model provides a way to overcome these barriers. Telerehabilitation could be easily integrated into the VA Care Coordination Home Telehealth initiatives and the myHealtheVet web portal. .

描述(由申请人提供)： 这项拟议的研究的目的是在患有多发性硬化症(MS)等衰弱神经系统疾病的退伍军人中建立基于家庭的物理远程康复模式的临床价值，并就使用这项技术进行护理协调提供循证建议。本研究的主要目的是在为期6个月的随机对照试验中，确定基于家庭的物理远程康复对患有多发性硬化症的退伍军人功能结果的影响。基本假设是：与对照组相比，身体远程康复将导致Berg平衡量表评分提高15%，6个月后定时25英尺步行减少3秒。该项目的次要目标包括检查身体远程康复对症状活动的影响，以及6个月后的行为-心理-社会结果。这项研究将利用排列区组随机设计来比较家庭物理远程康复(干预)和常规康复护理(对照)在退伍军人和多发性硬化症患者中的效果。根据利用我们的试点研究数据进行的能量分析，所需的总样本量为108。符合条件的多发性硬化症退伍军人样本将在VISN 5中招募，并随机分配到干预组和对照组。按两个扩展的残疾状况量表分组(EDSS 2.0-4.0和EDSS 4.5-6.5)也将随机分成这些组。登记参加干预组的患者将收到一个家庭自动远程医疗(HAT)系统，该系统将由研究助理安装在患者的家中。干预组和对照组都将接受为期6个月的个体化理疗计划，并将接受如何执行锻炼计划的培训。经过基线评估后，干预组患者将接受计算机中介的支持，每天通过家中的HAT遵循他们的个性化运动计划。研究结果评估将在3个月和6个月时由一个由物理治疗师和执业护士组成的盲目临床小组进行。远程康复的临床影响将在三个主要领域进行评估：功能状态、症状活动以及行为和心理社会领域。主要结果将是两组之间通过定时25英尺步行和Berg平衡量表评估患者功能状态的分数的差异。功能状态还将使用6分钟步行、MS步行量表、MS功能复合体和EDSS进行评估。症状活动度将是使用修改后的疲劳影响量表和MS影响量表评估的次要结果。行为和心理社会领域的其他次要结果将包括多发性硬化症自我效能量表、抑郁症状和特定疾病的生活质量。这项研究的结果将为使用现代电信技术改善患有衰弱的慢性神经疾病的退伍军人的护理提供重要信息。距离、残疾和缺乏适当的专家往往限制了访问 在退伍军人保健系统内提供康复服务，拟议的远程康复模式提供了一种克服这些障碍的方法。远程康复可以很容易地整合到退伍军人管理局护理协调家庭远程健康倡议和myHealtheVet门户网站中。。