Rehabilitation of Executive Function in Aging Veterans with History of TBI

本项目的目标是调查利用技术实现家庭- 为有创伤性脑损伤（TBI）病史的老年退伍军人提供基于执行功能的培训。 背景：注意力和执行控制问题是TBI最常见的后遗症， 这些认知区域也很容易老化。目标导向的注意力自我 调节（目标）是一种手动认知训练干预的问题，注意和执行 已被证明可以改善平民和退伍军人的认知、情感和功能结果的控制 有TBI病史的患者，包括65岁及以上的退伍军人和健康的老年人。 与退伍军人健康的相关性和重要性：TBI在退伍军人中普遍存在。家庭远程保健 (HBT)可能是解决老年退伍军人缺乏医疗保健的有效工具。 目标1：通过以下方式完全调整IP-GOALS协议：a）HBT使用和B）老年退伍军人使用 收集来自[n=8]具有TBI和认知主诉病史的65岁以上退伍军人的反馈。目标2：检查 可行性（定义为招募率、随机化后脱落率、保留率和依从性），以及 在n=36名有TBI和认知障碍病史的65岁以上退伍军人中，参与者评定[IP和] HBT-GOALS的可接受性 投诉假设2：可行性将通过实现有针对性的招聘目标来证明， 在随机化、保留和依从性后的合理脱落率，以及高水平的参与者评分 两组的可接受性。目标3：使用双变量估计[HBT-GOALS和IP-GOALS]的效应量。 基线对照]对改善a）认知表现和自我报告B）情绪调节和c）每日 在相同的目标2研究队列中发挥作用，以告知未来临床试验的样本量要求。 假设3：效应量估计值将提供以下方面的临床有意义的改善证据：a）认知能力 功能（注意力和执行功能复合物），B）情绪调节（情绪状态概况 总情绪障碍评分），和c）日常功能结果（梅奥-波特兰适应性量表总 得分）。探索性分析a）将检查退伍军人的特征（例如，年龄、性别、家庭/照顾者 支持、到最近诊所的距离以及包括慢性疼痛在内的健康/行动问题）与 参与者评定的可接受性和可行性的差异（即，招募率，随机化后脱落， 保留和依从性），以及[IP/HBT-GOALS的应答vs.双基线对照。]探索性 分析B）将检查应答的分布，以选择标准来定义未来研究中的应答者。 方法：适应阶段（目标1）：针对a）HBT使用和B）使用对现有GOALS方案进行适应性调整 将通过收集培训后的可行性和可接受性数据来完成对老年退伍军人的培训。试验阶段 (Aims 2和3以及探索性分析）：可行性、可接受性、认知、情感和日常功能 将从n=36名65岁或以上的退伍军人中收集数据， 亲自（IP）或通过HBT参加GOALS培训。退伍军人将被随机分配到IP 或HBT。结果测量包括参与者评定的可接受性;可行性（即，招募率，辍学率 随机化、保留和依从性后）;神经认知功能的标准化和验证措施 功能;抑郁症、创伤后应激障碍、情绪障碍和日常功能症状的自我报告 创新：拟议的研究是第一个调查实施既定的认知 康复干预用于有TBI病史和在家分娩的老年退伍军人 视频会议技术。 意义：这项研究可能会促进改善有TBI病史的老年退伍军人的日常功能 通过恢复执行功能，并增加获得这种治疗的机会。

The goal of this project is to investigate the feasibility and acceptability of using technology to implement home- based executive function training for aging Veterans with history of traumatic brain injury (TBI). Background: Problems with attention and executive control are some of the most common sequelae of TBI, and these areas of cognition are also known to be vulnerable to aging. Goal Oriented Attentional Self- Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults. Relevance and significance to Veteran’s health: TBI is prevalent among Veterans. Home-based telehealth (HBT) may be an effective tool to address lack of access to health care for aging Veterans. Aim 1: Complete adaptation of the IP-GOALS protocol for a) HBT use and b) use with older Veterans via collection of feedback from [n=8] Veterans 65+ with history of TBI and cognitive complaints. Aim 2: Examine the feasibility (defined as recruitment yield, dropout after randomization, retention, and adherence) and participant-rated acceptability of [IP and] HBT-GOALS in n=36 Veterans 65+ with history of TBI and cognitive complaints. Hypothesis 2: Feasibility will be demonstrated by achieving targeted recruitment goals with reasonable rates of dropout after randomization, retention, and adherence, and high levels of participant-rated acceptability in both groups. Aim 3: Estimate effect sizes for [HBT-GOALS and IP-GOALS using a double- baseline control] on improving a) cognitive performance and self-reported b) emotional regulation and c) daily functioning in the same Aim 2 study cohort to inform sample size requirements for a future clinical trial. Hypothesis 3: Effect size estimates will provide evidence of clinically meaningful improvement on a) cognitive functioning (Attention and Executive Function Composite), b) emotional regulation (Profile of Mood States Total Mood Disturbance Score), and c) daily functioning outcomes (Mayo-Portland Adaptability Inventory Total Score). Exploratory analysis a) will examine whether Veteran characteristics (e.g., age, sex, family/caregiver support, distance to nearest clinic, and health/mobility issues including chronic pain) are associated with differences in participant-rated acceptability and feasibility (i.e., recruitment yield, dropout after randomization, retention and adherence), and [response to IP/HBT-GOALS vs. double baseline control.] Exploratory analysis b) will examine distribution of responses to select criteria to define responders in future studies. Methods: Adaptation phase (Aim 1): Adaptation of the existing GOALS protocol for a) HBT use and b) use with older Veterans will be completed by collecting post-training feasibility and acceptability data. Pilot phase (Aims 2 and 3 and Exploratory Analyses): Feasibility, acceptability, cognitive, emotional, and daily functioning data will be collected from n=36 Veterans 65 or older before (baseline and delay baseline) and after participation in GOALS training delivered in person (IP) or via HBT. Veterans will be randomly assigned to IP or HBT. Outcome measures include participant-rated acceptability; feasibility (i.e., recruitment yield, dropout after randomization, retention, and adherence); standardized and validated measures of neurocognitive functioning; self-report of symptoms of depression, PTSD, mood disturbance, and daily functioning Innovation: The proposed study is the first to investigate implementation of an established cognitive rehabilitation intervention for use with aging Veterans with history of TBI and delivery via in-home videoconferencing technology. Implications: This research may promote improved daily functioning for aging Veterans with history of TBI through rehabilitation of executive function, and increase access to such treatment.