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

摘要 几十年来，这个国家迅速老龄化的人口和日益增长的对家庭照顾者的需求一直被呼吁 请注意。事实上，随着较早的医院出院，对照顾者的要求继续加剧。这 可能在接受异基因造血细胞移植的患者的照顾者中最为明显。 在过去的三十年里，护理者干预被证明在改善护理者方面是有效的 幸福。然而，他们中的大多数都专注于照顾的负面方面(例如，负担)， 很少有人关注照料的积极方面(例如，福利)。此外，结果传统上依赖于 长期召回和快照自我报告。因此，人们对行动机制的了解有限。 是一次干预。移动医疗技术已被证明可以提供灵活、省时、省钱的服务 干预措施，以支持整个护理轨迹的照顾者，并使收集连续的，多个 参数生理数据。这些高度时间分辨的参数与快照自我报告数据相关联 有可能为干预提供新的机械性见解。这项提议的目的是利用 提供一种新的面向照顾者的移动健康干预的技术，该框架由 卡博诺关于照顾的积极方面。我们的跨学科团队将把我们最近取得的成功 开发多组件、面向护理者的移动健康产品(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，一个多- 关注照护的积极方面的组件技术中介干预将得到改善 照顾者的幸福。研究将分两个阶段进行。在第一阶段，我们将确定积极的 构建反映不同利益相关者之间的护理流程的结构，通过新的 组件，并通过迭代的以用户为中心的设计流程试行测试Roadmap 2.0。第二阶段将涉及 一项双臂研究设计，参与者将被随机分配到治疗臂(移动平台路线图 2.0)或在基线评估之后到控制臂(移动平台日常护理)。研究的持续时间 将包括一个积极的~18周的干预阶段。我们将招募并随机挑选约166名照顾者和患者 (总计332个)。参与者将在移植后的基线、第30天和第120天接受评估。主要结果是 措施将是护理人员在第120天促进全球健康。次要措施将包括评估指标 幸福的积极方面(例如，自我效能、积极的情感)和幸福的消极方面(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，以 根据护理者和患者的结果确定系统中活跃和不活跃的组件。我们还将 采用新的数据驱动方法，进一步确定最佳干预组件、剂量和时间， 可以在今后的工作中加以检验。我们的长期目标是实现和传播一个可扩展的产品， 增强照顾者的健康和福祉，同时无缝地融入他们的日常生活。

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.