A Self-Management Program for Improving the Well-Being of Veterans with AIS D Incomplete Spinal Cord Injury

背景和意义：脊髓损伤（Spinal cord injury，SCI）是一种改变生命的事件，经常导致永久性的 瘫痪和感觉丧失，随后丧失身体功能和独立性，并有阴性风险 心理社会结果。大约25-51%的成人获得性SCI患者患有AIS D SCI， 预后为截肢，是不太明显的残疾，一般有更好的客观福祉，如 社区融合和流动性。然而，与直觉相反的是，患有AIS D SCI的退伍军人的发病率更高， 主观幸福感（SWB）较差的风险，包括抑郁和自杀意念的发生率较高。几 已经提出了可能解释幸福差异的因素，包括不太严重的康复 服务，工具和社会支持网络的发展有限，合并症的患病率较高 健康问题和不发达的残疾人身份。鉴于主观幸福感是生活质量的核心， 了解和培养那些技能，观点和资源，最好地支持后SCI的主观幸福感。 具体目标：本研究将制定针对退伍军人福祉的第一项干预措施， AIS D SCI通过使用自我管理方法来满足他们的特定需求。自我管理 (SM)方案通过促进参与、知识和权威来区分，以直接照顾 病人一个以SM为导向的计划，针对AIS退伍军人的需求和治疗偏好量身定制 D SCI对改善福祉大有希望。因此，拟议的研究将发展SCI自我- AIS D管理（SCISM-D）计划，一个单独管理的，个性化的支持和技能 通过退伍军人事务部的视频远程医疗技术进行培训干预，以改善退伍军人的福祉 AIS D SCI。这项研究是非常重要的退伍军人医疗保健，作为创建拟议的 SCISM-D计划有望填补关键的医疗保健空白，并改善终身心理社会 为患有AIS D SCI的退伍军人提供服务。本研究有三个目的：（目的1）开发SCISM-D， 使用初步研究和焦点小组对患有AIS D SCI的退伍军人的主观幸福感进行研究。(Aim（2）进行a 进行试点研究，以改进SCISM-D，并测试SCISM-D的可行性和可接受性，为未来 随机对照试验。(Aim 3）完成SCISM-D计划手册和消费者手册。 研究计划：就目的1而言，两个焦点小组，每组4-6名患有AIS D SCI的退伍军人，以及两个焦点小组，每组4-6名SCI 在两次会议期间，将招募供应商对SCISM-D的拟议组成部分进行审查、评级和讨论 每个.根据焦点小组的评分和反馈，SCISM-D计划手册和消费者 将编制手册。各个程序组件将根据现有SM手册进行调整， 其他的由研究人员开发。完成的程序手册和消费者手册将 提交重点小组和专家小组征求反馈意见，然后进行最后一轮修订。标准 成功包括根据研究时间轴完成重点小组和材料。 接下来，将进行一项试点研究，以检查SCISM-D的可行性，并随后进行随机 对照试验（目标2）。目标是20名患有AIS D SCI的退伍军人将完成这项研究。SCISM-D预计 涉及5-7，45-60分钟的会议通过退伍军人管理局的远程医疗系统进行。几项措施和 访谈将在计划期间进行，以评估治疗收益和介质。标准 成功包括每月至少招募2名参与者，至少75%的保留率，至少75%的保留率， 患者满意度，信心和生活满意度的平均变化为“最小改善”， 他人试点研究结束后，焦点小组成员将被要求审查SCISM-D计划草案 手册和消费者手册，以告知调查小组对内容的最后修订， 专业设计师（目标3）。

Background and Significance: Spinal cord injury (SCI) is a life-altering event that often results in permanent paralysis and sensory loss, with subsequent loss of physical function and independence and risk for negative psychosocial outcomes. About 25-51% of adults with acquired SCI have AIS D SCI and have an excellent prognosis for ambulation, are less visibly disabled, and generally have better objective well-being, such as community integration and mobility. However, counterintuitively, military Veterans with AIS D SCI are at higher risk of poor subjective well-being (SWB) including higher rates of depression and suicidal ideation. Several factors that may explain the disparity in well-being have been proposed, including less acute rehabilitation services, limited development of instrumental and social support networks, greater prevalence of comorbid health issues, and underdeveloped disability identity. Given that SWB is central to quality of life, it is essential to understand and foster those skills, perspectives, and resources that best support SWB after SCI. Specific Aims: This study will develop the first intervention targeting the well-being of Veterans with AIS D SCI by attending to their specific needs using a self-management approach. Self-management (SM) programs are differentiated by fostering engagement, knowledge, and authority to direct care to the patient. An SM-oriented program that is tailored to the needs and treatment preferences of Veterans with AIS D SCI has great promise to improve well-being. For this reason, the proposed study will develop the SCI Self- Management for AIS D (SCISM-D) Program, an individually administered, personalized support and skills training intervention via the VA’s video telehealth-to-home technology, to improve well-being among Veterans with AIS D SCI. This study is highly significant for Veteran health care, as creation of the proposed SCISM-D program is expected to fill a critical health care gap and improve lifetime psychosocial functioning for Veterans with AIS D SCI. This study has three aims: (Aim 1) Develop SCISM-D to enhance the SWB of military Veterans with AIS D SCI using preliminary research and focus groups. (Aim 2) Conduct a pilot study to improve SCISM-D and test the feasibility and acceptability of SCISM-D to prepare for a future randomized controlled trial. (Aim 3) Finalize the SCISM-D program manual and consumer handbook. Research Plan: For Aim 1, two focus groups of 4-6 Veterans with AIS D SCI and two focus groups of 4-6 SCI providers will be recruited to review, rate, and discuss proposed components of SCISM-D during two meetings each. Informed by the focus group ratings and feedback, the SCISM-D program manual and consumer handbook will be developed. Individual program components will be adapted from extant SM manuals with others developed by the investigators. The completed program manual and consumer handbook will then be presented to the focus groups and expert panel for feedback, followed by a final round of revisions. Criteria for success include completion of the focus groups and materials according to the study timeline. Next, a pilot study will be conducted to examine the feasibility of SCISM-D and a subsequent randomized controlled trial (Aim 2). A target of 20 Veterans with AIS D SCI will complete the study. SCISM-D is anticipated to involve 5-7, 45-60-minute sessions conducted via the VA’s telehealth system. Several measures and interviews will be administered during the program to assess treatment gains and mediators. Criteria for success include the ability to recruit at least 2 participants per month, at least 75% retention, at least 75% patient satisfaction, and an average change of “minimally improved” in confidence and life satisfaction, among others. After the pilot study, the focus group members will be asked to review the draft SCISM-D program manual and consumer handbook to inform final revisions to content by the team of investigators and layout by professional designers (Aim 3).