Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability

使用生物行为方法让医学复杂的退伍军人参与远程康复：可行性和可接受性的试点研究

• 批准号: 10251603
• 负责人: Jennifer E. Stevens-Lapsley
• 金额: --
• 依托单位: VA EASTERN COLORADO HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10251603
• 关键词: Accelerometer; Achievement; Acute; Address; Adherence; Adverse event; Cardiac; Caring; Clinical; Communities; Complex; Cross-Over Studies; Crossover Design; Data Analyses; Disease; Dose; Education; Elderly; Enrollment; Exercise; Feedback; Gait speed; Geriatrics; Health Promotion; Health Services Accessibility; Home; Home environment; Hour; Impairment; Intervention; Investigation; Lead; Life; Loneliness; Long-Term Care; Measures; Medical; Methods; Modeling; Motivation; Nature; Outcome; Participant; Patient Self-Report; Patients; Persons; Physical Function; Physical activity; Physiological; Pilot Projects; Population; Preparation; Protocols documentation; Provider; Quality of life; Randomized; Rehabilitation therapy; Research; Research Design; Residual state; Resources; Risk; Role; Rural; Safety; Sample Size; Sampling; Self Management; Site; Social isolation; Social support; Stroke; Structure; Techniques; Technology; Training; Translating; Transportation; Underserved Population; Veterans; Veterans Health Administration; Vulnerable Populations; Work; acceptability and feasibility; adverse event monitoring; arm; attentional control; base; behavior change; beneficiary; biobehavior; care costs; comorbidity; design; effectiveness trial; evidence base; exercise prescription; experience; functional decline; high risk; improved; improved outcome; innovation; novel; novel strategies; outpatient programs; patient population; physical inactivity; preservation; prevent; programs; randomized trial; rehabilitation paradigm; rehabilitation service; response; rural area; rurality; sedentary lifestyle; strength training; telehealth; telerehabilitation; theories; trend; virtual; virtual delivery; Accelerometer; Achievement; Acute; Address; Adherence; Adverse event; Cardiac; Caring; Clinical; Communities; Complex; Cross-Over Studies; Crossover Design; Data Analyses; Disease; Dose; Education; Elderly; Enrollment; Exercise; Feedback; Gait speed; Geriatrics; Health Promotion; Health Services Accessibility; Home; Home environment; Hour; Impairment; Intervention; Investigation; Lead; Life; Loneliness; Long-Term Care; Measures; Medical; Methods; Modeling; Motivation; Nature; Outcome; Participant; Patient Self-Report; Patients; Persons; Physical Function; Physical activity; Physiological; Pilot Projects; Population; Preparation; Protocols documentation; Provider; Quality of life; Randomized; Rehabilitation therapy; Research; Research Design; Residual state; Resources; Risk; Role; Rural; Safety; Sample Size; Sampling; Self Management; Site; Social isolation; Social support; Stroke; Structure; Techniques; Technology; Training; Translating; Transportation; Underserved Population; Veterans; Veterans Health Administration; Vulnerable Populations; Work; acceptability and feasibility; adverse event monitoring; arm; attentional control; base; behavior change; beneficiary; biobehavior; care costs; comorbidity; design; effectiveness trial; evidence base; exercise prescription; experience; functional decline; high risk; improved; improved outcome; innovation; novel; novel strategies; outpatient programs; patient population; physical inactivity; preservation; prevent; programs; randomized trial; rehabilitation paradigm; rehabilitation service; response; rural area; rurality; sedentary lifestyle; strength training; telehealth; telerehabilitation; theories; trend; virtual; virtual delivery

Older Veterans with multiple comorbidities or medically complexities represent one of the most vulnerable patient populations. This large and growing proportion of Veterans Health Administration (VHA) beneficiaries are more likely to live in rural areas, experience social isolation and loneliness, and be physically inactive. Thus, medically complex older Veterans are at greater risk for progressive declines in function, lower quality of life, and frequent care needs. While the VHA has established outpatient programs to address rehabilitation needs, these programs tend to serve disease-specific populations (e.g. cardiac, stroke). Moreover, these programs often do not meet the needs of medically complex older Veterans, as they typically 1) require in- person attendance, 2) under-dose the physiologic intensity of rehabilitation, and 3) lack self-management approaches for preservation of function. Telehealth platforms offer a solution to redesign rehabilitation models of care for medically complex older Veterans and can aid in overcoming access barriers (rurality, transportation), while also integrating technologies to augment biobehavioral interventions and provide social support. Novel, scalable telerehabilitation approaches targeting medically complex older Veterans are urgently needed to 1) address physiologic impairments using progressive, high-intensity rehabilitation, 2) increase physical inactivity with biobehavioral interventions which promote self-management, and 3) reduce social isolation and loneliness via social support. Therefore, we propose a pilot, two-arm randomized trial using a crossover study design to determine the feasibility, acceptability, and safety (AIM 1) of a 12-week multicomponent telerehabilitation program. We will also measure Veterans’ clinical outcomes to explore the preliminary response to the program and to determine variability estimates for outcomes (AIM 2) in preparation for a larger investigation. This study will enroll 50 medically complex older Veterans who are designated as “high-need, high-risk” using a definition provided by the Geriatrics & Extended Care Data & Analysis Center. Veterans will be randomized to GROUP1 or GROUP2 (25 participants in each group); GROUP1 will receive the 12-week intervention, and GROUP2 will receive attention control consisting of 1-hour education sessions delivered every 2 weeks (6 total). GROUP2 will then crossover to the intervention at the completion of 12- weeks. Outcomes will be assessed at baseline (pre-intervention), 6 weeks (intervention mid-point), 12 weeks (end of intervention), and 24 weeks. Achievement of the proposed aims will establish feasibility and preliminary response of a novel, multicomponent telerehabilitation program that critically addresses the multitude of interrelated complexities unique to older Veterans who are currently underserved by traditional rehabilitation paradigms. This work will directly translate to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches. Study findings will have immediate clinical impact as they will guide implementation of safe and effective telerehabilitation programs as alternatives to in-person rehabilitation for medically complex older Veterans.

具有多种合并症或医学复杂性的老年退伍军人代表了最脆弱的人之一 患者人群。退伍军人卫生管理局（VHA）受益人的这一庞大比例 更有可能生活在粗糙的地区，经历社会隔离和孤独感，并且身体不活跃。 这就是医学上复杂的老年退伍军人的功能下降的风险更大，质量较低 生活，经常关心需求。 VHA建立了门诊计划以解决康复 需求，这些计划倾向于为疾病特异性人群提供服务（例如心脏，中风）。而且，这些 程序通常无法满足医学上复杂的老年退伍军人的需求，因为他们通常1）需要 人出勤率，2）剂量不足的身体康复强度，3）缺乏自我管理 保存功能的方法。远程医疗平台为康复模型提供了解决方案 对医学复杂的老年退伍军人进行护理，并可以帮助克服访问障碍（Rurality，Rurality， 运输），同时还整合技术以增强生物行为干预措施并提供社交 支持。针对医学复杂的老年退伍军人的新型，可扩展的远程临时方法是紧急的 需要1）使用进行性高强度康复的生理障碍解决生理障碍，2）增加 促进自我管理的生物行为干预措施的身体不活跃，3）减少社会 通过社会支持孤立和孤独。因此，我们提出了一项使用A的飞行员，两臂随机试验 跨界研究设计以确定12周的可行性，可接受性和安全性（AIM 1） 多组件电信计划。我们还将衡量退伍军人的临床结果，以探索 对程序的初步响应，并确定预后的可变性估计（AIM 2） 进行更大的调查。这项研究将招募50名被指定为 使用老年医学和扩展护理数据与分析中心提供的定义，“高需求，高风险”。 退伍军人将被随机分为Group1或Group2（每个组的25名参与者）； Group1将收到 为期12周的干预措施和Group2将获得由1小时教育课程组成的注意力控制 每2周交付一次（总共6个）。然后，Group2将在完成12-的完成时进行跨越干预措施。 几周。结果将在基线（干预前），6周（干预中点），12周评估 （干预结束）和24周。提出的目标的实现将确定可行性和初步 一个新颖的多组分电启动程序的响应，该程序批判性地解决了多大程度 相互关联的复杂性是年长的退伍军人所特有的，他们目前遭受传统康复的服务不足 范式。这项工作将直接转化为其他医学复杂和服务不足的人群 受益于创新的Telerehabilitation Care方法。研究发现将立即产生临床影响 因为他们将指导实施安全有效的远程居民计划作为面对面的替代方案 医学上复杂的老年退伍军人的康复。