Heart failure is a complex syndrome that contributes significantly to mortality and morbidity in the Unites States. Self-management is an ACC/AHA-recommended management tool for chronic conditions, however, those with congestive heart failure have historically poor compliance, low health literacy, and comorbidities that lead to reduced adherence to therapies and lifestyle modifications. Digital health technologies have the potential to enhance care and improve self-management. This manuscript describes the rationale and challenges of the design and implementation of a pragmatic randomized controlled trial to evaluate the efficacy of three digital health technologies in the management of congestive heart failure. Leveraging the use of a fully electronic enrollment and consent platform, the trial will randomize 200 patients across heart failure clinics in the Yale New Haven Health system to receive either usual care or one of three distinct digital technologies designed to promote self-management and provide critical data to clinicians. Our primary outcome will measure the change in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 months. Initial recruitment efforts have highlighted the large digital divide in our population of interest. Assessing not only clinical outcomes, but patient usability and ease of clinical integration of digital technologies will prove beneficial in determining the feasibility and success of the integration of such technologies into the healthcare system. Future learnings will illustrate strategies to improve patient engagement with, and integration of, digital health technologies to enhance the patient-clinician relationship.

中文翻译：

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评估数字健康技术对充血性心力衰竭患者生活质量影响的实用随机试验：设计和原理

心力衰竭是一种复杂的综合征，在美国会显着增加死亡率和发病率。自我管理是 ACC/AHA 推荐的慢性病管理工具，然而，充血性心力衰竭患者历来依从性差、健康素养低和合并症，导致对治疗和生活方式改变的依从性降低。数字健康技术有潜力加强护理和改善自我管理。这份手稿描述了设计和实施一项实用的随机对照试验以评估三种数字健康技术在治疗充血性心力衰竭中的功效的基本原理和挑战。利用完全电子化的注册和同意平台，该试验将在耶鲁纽黑文健康系统的心力衰竭诊所随机抽取 200 名患者，接受常规护理或旨在促进自我管理并向临床医生提供关键数据的三种不同数字技术中的一种。我们的主要结果将衡量堪萨斯城心肌病问卷 (KCCQ) 在 3 个月时评估的生活质量变化。最初的招聘工作凸显了我们感兴趣的人群中巨大的数字鸿沟。不仅要评估临床结果，还要评估患者的可用性和数字技术临床集成的难易程度，这将有助于确定将此类技术集成到医疗保健系统中的可行性和成功性。未来的学习将说明改善患者参与和整合的策略，