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）： 拟议研究的目的是建立一个家庭为基础的物理远程康复模型的临床价值在veteranswith衰弱的神经系统条件，如多发性硬化症（MS），并提供基于证据的建议，使用这种技术的护理协调。 本研究的主要目的是在一项为期6个月的随机对照试验中确定家庭物理远程康复对MS退伍军人功能结局的影响。主要假设是：与对照组相比，物理远程康复将导致贝格平衡量表评分提高15%，6个月时定时25英尺步行减少3秒。该项目的次要目的包括检查身体远程康复对症状活动的影响，以及6个月时的行为-心理社会结果。 本研究将采用排列区组随机设计，比较家庭物理远程康复（干预）与常规康复护理（对照）在MS退伍军人中的效果。基于利用我们的试点研究数据的功效分析，所需的总样本量为108。将在VISN 5内招募符合条件的MS退伍军人样本，并随机分配至干预组和对照组。还将根据两个扩展残疾状态量表组（EDSS 2.0-4.0和EDSS 4.5-6.5）对随机分组进行分层。参加干预组的患者将获得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家中。干预组和对照组将在6个月的研究期间接受个性化的物理治疗计划，并接受如何执行运动计划的培训。在基线评估后，干预组的患者将接受计算机介导的支持，每天在家中通过HAT遵循他们的个性化运动计划。 由物理治疗师和执业护士组成的设盲临床团队将在3个月和6个月时进行研究结局评价。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。主要结局将是通过定时25英尺步行和贝格平衡量表评估患者功能状态的评分的组间差异。还将使用6分钟步行、MS步行量表、MS功能复合量表和EDSS评估功能状态。症状活动性将是使用改良疲劳影响量表和MS影响量表估计的次要结局。行为和心理社会领域的其他次要结果包括MS自我效能量表、抑郁症状和疾病特异性生活质量。 这项研究的结果将提供关于使用现代电信技术改善患有慢性神经系统疾病的退伍军人护理的重要信息。距离、残疾和缺乏适当的专家往往限制了获得服务的机会 康复服务的VA医疗保健系统内，和拟议的远程康复模式提供了一种方法来克服这些障碍。远程康复可以很容易地集成到VA护理协调家庭远程保健倡议和myHealthVet门户网站。. 公共卫生关系： 本研究的主要目的是建立以家庭为基础的物理远程康复的价值与衰弱的慢性疾病，如多发性硬化症（MS）的退伍军人，并提供使用这种技术的护理协调的建议。 退伍军人事务部有义务为所有退伍军人提供一致的护理，无论他们住在哪里，也无论他们残疾有多严重。退伍军人事务部通过资助两个MS卓越中心（MSCoE）和最近批准MS护理政策手册，表明了对MS退伍军人的承诺。主要研究者和共同主要研究者都是欧洲经济和社会理事会东部办事处的工作人员，这一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获得和提供的方法。