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

摘要 几十年来，美国人口迅速老龄化，对家庭护理人员的需求不断增加， 关注事实上，随着出院时间的提前，对护理人员的要求继续增加。这 在接受异基因造血细胞移植的患者的护理者中可能最明显。 在过去的三十年里，护理人员的干预措施已被证明是有效的，在改善护理人员 well-being.然而，他们中的大多数人都集中在负面的影响（例如，（重定向自Very 很少有人集中在积极的方面（例如，利益）。此外，结果传统上依赖于 长期回忆和快速自我报告。因此，对作用机制的了解有限 一个干预。事实证明，移动的医疗技术可以提供灵活、节省时间和成本的服务 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 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 有可能提供新的干预机制的见解。本提案的目的是利用 技术提供一种新的面向患者的移动的健康干预， 卡尔博诺的积极方面。我们的跨学科团队将利用我们最近的成功， 开发一个多组件的、面向全世界的移动的健康产品（BMT路线图），并进一步扩大和 在随机对照试验中测试干预措施（路线图2.0）。我们的核心假设是，一个多- 以技术为媒介的干预措施，重点放在积极方面， 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 反映不同利益相关者之间的协商过程的结构， 组件，并通过迭代的以用户为中心的设计过程对Roadmap 2.0进行试点测试。第二阶段将涉及 两组研究设计，受试者将被随机分配至治疗组（移动的平台+路线图 2.0)或在基线评估后转移到对照组（移动的平台+常规护理）。研究期间 将涉及一个积极的~18周的干预阶段。我们将招募并随机分配约166名护理人员和患者 (332共计）。将在基线、移植后第30天和第120天对参与者进行评估。主要结局 在第120天，将测量护理者PROMIS全球健康。次级措施将包括指数评估 幸福的积极方面（例如，自我效能，积极影响）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， 根据护理人员和患者的结果确定系统的活动和不太活动的组件。我们还将 采用新的数据驱动方法，进一步确定最佳干预成分、剂量和时间， 可以在今后的工作中加以研究。我们的长期目标是实现和推广一个可扩展的产品， 增强护理人员的健康和福祉，同时无缝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.