Roadmap 2.0: A randomized controlled trial using a technology-mediated platform in family caregivers of BMT patients

路线图 2.0：在 BMT 患者的家庭护理人员中使用技术介导的平台进行的随机对照试验

• 批准号: 9883837
• 负责人: SUNG WON CHOI
• 金额: $ 35.1万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9883837
• 关键词: Affect; Agreement; Allogenic; Anxiety; Attention; Blood; Bone Marrow Transplantation; Caregiver support; Caregiver well-being; Caregivers; Caring; Cessation of life; Clinical; Collection; Data; Data Analyses; Data Analytics; Data Reporting; Development; Disease; Electronic Health Record; Ensure; Evaluation; Exercise; Face; Family Caregiver; Fatigue; Future; Goals; Health; Health Technology; Healthcare; Hematological Disease; Hospitals; Immunotherapy; Intervention; Interview; Knowledge; Lead; Measures; Mediating; Mental Depression; Methods; National Heart, Lung, and Blood Institute; Outcome; Outcome Measure; Participant; Patient Self-Report; Patient-Focused Outcomes; Patients; Personal Satisfaction; Phase; Physical activity; Physiological; Prevalence; Procedures; Process; Randomized; Randomized Controlled Trials; Recovery; Research Design; Risk; Role; Science; Self Efficacy; Sleep; Sleep Disorders; Sleep disturbances; Surveys; System; Tablets; Technology; Testing; Time; Training; Training and Education; Transplant Recipients; Variant; Vision; Work; aging population; arm; base; burnout; caregiver interventions; caregiving; cost; disorder risk; dosage; education resources; efficacy testing; evidence base; flexibility; global health; health care model; health care service utilization; hematopoietic cell transplantation; high risk; improved; indexing; innovation; insight; mHealth; mobile computing; multidisciplinary; novel; patient safety; post-transplant; primary outcome; psychologic; public health priorities; public health relevance; recruit; safe patient; secondary outcome; side effect; skills; skills training; social; success; transplant survivor; treatment arm; treatment as usual; two-arm study; user centered design; wearable sensor technology

ABSTRACT For decades, the nation’s rapidly aging population and rising need for family caregivers have been called to attention. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. This is perhaps most pronounced in caregivers of patients undergoing allogeneic hematopoietic cell transplantation. Over the last three decades, caregiver interventions have been shown to be effective in improving caregiver well-being. However, most of them have focused on the negative aspects of caregiving (e.g., burden) with very few focused on the positive aspects of caregiving (e.g., benefit). Further, outcomes have traditionally relied on long-term recall and snapshot self-report. Thus, there has been limited understanding of the mechanism of action of an intervention. Mobile health technology has been shown to deliver flexible and time- and cost-sparing interventions to support caregivers across the care trajectory and enable the collection of continuous, multi- parameter physiological data. These highly time-resolved parameters correlated with snapshot self-report data have potential to provide new mechanistic insights of an intervention. The objective of this proposal is to leverage technology to deliver a novel caregiver-facing mobile health intervention guided by a conceptual framework of Carbonneau’s positive aspects of caregiving. Our interdisciplinary team will take our recent success of developing a multi-component, caregiver-facing mobile health product (BMT Roadmap) and further expand and test the intervention (Roadmap 2.0) in a randomized controlled trial. Our central hypothesis is that a multi- component technology-mediated intervention with focus on the positive aspects of caregiving will improve caregiver well-being. The study will be conducted in two phases. During Phase 1, we will identify positive constructs that reflect that caregiving process among diverse stakeholders, expand the system with new components, and pilot test Roadmap 2.0 through an iterative user-centered design process. Phase 2 will involve a two-arm study design where participants will be randomized to a treatment arm (mobile platform + Roadmap 2.0) or to a control arm (mobile platform + usual care) following a baseline assessment. The duration of the study will involve an active ~18-week intervention phase. We will recruit and randomize ~166 caregivers and patients (332 total). Participants will be assessed at baseline, day 30, and day 120 post-transplant. The primary outcome measure will be caregiver PROMIS Global Health at day 120. Secondary measures will include indices assessing positive aspects of well-being (e.g., self-efficacy, positive affect) and negative aspects of well-being (e.g., depression, anxiety, sleep disturbance). We will conduct a rigorous mixed methods process evaluation to determine the active and less active components of the system on caregiver and patient outcomes. We will also employ a novel data-driven approach to further identify optimal intervention components, dosage, and time that can be examined in future work. Our long-term goal is to implement and disseminate a scalable product that enhances caregiver health and well-being, while being seamlessly integrated into their daily lives.

抽象的 几十年来，该国的人口迅速老龄化以及对家庭照顾者的需求不断增加 注意力。确实，随着医院较早的出院，对看护人的要求继续加剧。这 在接受同种异体造血细胞移植的患者的护理人员中，可能是最明显的。 在过去的三十年中，护理人员干预措施已被证明有效地改善了护理人员 福利。但是，他们中的大多数都集中在护理（例如伯恩）的负面方面 很少有专注于照料的积极方面（例如收益）。此外，结果传统上是挽救的 长期召回和快照自我报告。那是对行动机制的了解有限 干预。移动卫生技术已被证明可以提供灵活，时间和成本的 干预措施以支持整个护理轨迹的护理人员，并能够收集连续的，多重的 参数物理数据。这些高度时间分辨的参数与快照自我报告数据相关 有潜力提供干预的新机械见解。该提议的目的是利用 通过概念框架的指导，提供针对面向护理人员的新型移动健康干预措施的技术 Carbonneau的照料积极方面。我们的跨学科团队将取得我们最近的成功 开发多组分，面向护理人员的移动健康产品（BMT路线图），并进一步扩展和 在随机对照试验中测试干预措施（路线图2.0）。我们的中心假设是多 组件技术介导的干预措施，重点是护理的积极方面 照顾者的幸福感。该研究将分为两个阶段。在第1阶段，我们将确定积极的 反映潜在利益相关者之间照顾过程的结构，通过新的 组件和试点测试路线图2.0通过迭代以用户为中心的设计过程。第2阶段将涉及 两臂研究设计，参与者将被随机分配到治疗臂（移动平台 +路线图 基线评估后，2.0）或控制臂（移动平台 +常规护理）。研究持续时间 将涉及一个活跃的〜18周干预阶段。我们将招募和随机分组〜166名护理人员和患者 （总计332）。参与者将在基线，第30天和第120天进行评估。主要结果 措施将是第120天的照顾者Promis全球健康。次要措施将包括指数评估 幸福感的积极方面（例如，自我效果，积极影响）和福祉的负面方面（例如， 抑郁，焦虑，睡眠障碍）。我们将进行严格的混合方法过程评估 在护理人员和患者预后确定系统的主动和较低的活性组成部分。我们也会 员工一种新型的数据驱动方法，以进一步识别最佳干预组件，剂量和时间 可以在以后的工作中进行检查。我们的长期目标是实施和传播可扩展的产品 增强护理人员的健康和福祉，同时无缝地融入他们的日常生活中。