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: 8277575
• 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/8277575
• 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 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. . PUBLIC HEALTH RELEVANCE: The main purpose of this study is to establish the value of home-based physical telerehabilitation in veterans with debilitating chronic conditions such as multiple sclerosis (MS) and to provide recommendations on the use of this technology for care coordination. The VA has an obligation to provide a consistent level of care to all veterans no matter where they live or how severely they are disabled. The VA has shown its commitment to veterans with MS by funding two MS Centers of Excellence (MSCoE) and recently approving the MS Policy Handbook for care. The PI and co- PI are on staff at the MSCoE-East and this innovative project will provide information on rehabilitation outcomes and ways to improve access and delivery of rehabilitation services.

描述（由申请人提供）： 拟议的研究的目的是建立在衰弱的神经系统状况（例如多发性硬化症（MS））中，基于家庭的物理居室居民模型的临床价值，并提供有关将该技术用于护理协调的循证建议。 这项研究的主要目的是确定在6个月的随机对照试验中，在6个月的随机对照试验中，基于家庭的物理型居民对MS退伍军人的功能结果的影响。主要的假设是：与对照组相比，物理型居室将提高Berg Balance量表评分的15％和3秒钟在6个月时的定时25英尺步行的提高15％。该项目的次要目的包括检查物理远离居民对症状活动的影响以及6个月时行为心理社会结局的影响。 这项研究将利用置换的块随机设计来比较有MS的退伍军人中家庭物理居室（干预）与常规康复护理（控制）的影响。基于利用我们的试点研究数据的功率分析，所需的总样本量为108。将在VISN 5中募集具有MS的合格退伍军人样本，并随机分为干预和对照组。这些组的随机分配也将通过两个扩展的残疾状态量表组（EDSS 2.0-4.0和EDSS 4.5-6.5）进行分层。参加干预组的患者将获得家庭自动远程医疗（HAT）系统，该系统将由研究助理安装在患者家中。干预组和对照组将在6个月的研究期内获得个性化的物理治疗计划，并将接受有关如何执行锻炼计划的培训。经过基线评估后，干预组的患者每天都会通过帽子在家里遵循其个性化的锻炼计划，从而获得计算机介导的支持。 由物理治疗师和护士从业者组成的盲人临床团队将在3个月零6个月的6个月内进行研究结果评估。远离居民的临床影响将在三个主要领域估算：功能状态，症状活动以及行为和社会心理领域。主要结果将是分数中的组之间的差异，以评估患者功能状态的25英尺步行和伯格平衡量表。功能状态还将使用6分钟步行，MS步行量表，MS功能复合材料和EDSS评估。症状活动将是使用修改后的疲劳冲击量表和MS冲击量表估计的次要结果。行为和心理社会领域的其他次要结果将包括MS自我效能感，抑郁症状和特定于疾病的生活质量。 这项研究的结果将提供有关使用现代电信技术来改善慢性神经系统疾病的退伍军人的重要信息。距离，残疾和缺乏适当的专家通常会限制访问 在VA医疗保健系统内的康复服务和拟议的Telerehabilitation模型提供了一种克服这些障碍的方法。可以轻松地将Telerehabicitation纳入VA护理协调家庭远程医疗计划和MyHealthevet Web门户网站。 。 公共卫生相关性： 这项研究的主要目的是在具有衰弱的慢性状况（例如多发性硬化症（MS））的退伍军人中建立基于家庭的物理居室的价值，并提供有关使用该技术进行护理协调的建议。 VA有义务为所有退伍军人提供一致的护理，无论他们在哪里或残疾人的严重程度。弗吉尼亚州通过资助了两个MS卓越中心（MSCOE），并批准了MS Policy手册的护理手册，从而表明了其对退伍军人的承诺。 PI和CO-PI是MSCOE-EAST的工作人员，该创新项目将提供有关康复成果的信息，以及改善康复服务的访问和交付方式。