Skeens Micah, Sezgin Emre, Stevens Jack, Landier Wendy, Pai Ahna, Gerhardt Cynthia
Center for Biobehavioral Health, Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, United States.
Nationwide Children's Hospital, Columbus, OH, United States.
JMIR Res Protoc. 2022 Jul 21;11(7):e39098. doi: 10.2196/39098.
In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in health care costs annually. In pediatrics, adherence is largely dependent on caregivers. In a high-risk hematopoietic stem cell transplant (HSCT) population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. The most successful adherence interventions, and thus improved clinical outcomes, have included mobile health (mHealth) reminder approaches and a direct measure of adherence.
This is a 3-phase project, with this protocol describing phase 2, to determine the usability and feasibility of an mHealth app (BMT4me) designed to promote adherence to immunosuppressant medication and to track symptoms among children who received HSCT.
This study uses an iterative convergent mixed methods design to develop and assess the usability and feasibility of an adherence digital health intervention. We will recruit 15 caregivers of pediatric patients receiving HSCT to complete user testing. Qualitative and quantitative data will be integrated to enhance and expand upon study findings.
Enrollment began in September 2021 and is ongoing. A total of 7 caregivers have enrolled. We anticipate completion by fall 2022. We anticipate high usability scores and a better understanding of unique features within the app that are needed for HSCT families post transplant. To date, usability scores among enrolled participants are greater than 70%. Feedback from qualitative interviews is being used to further adapt the app by adding specific weekly logs, call provider options, and voice to text.
This protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone app for caregivers of children receiving HSCT. The app was designed to improve immunosuppressant adherence and to track symptoms in the acute phase post discharge. Study findings will inform further refinement of the app and the feasibility of a pilot randomized controlled trial examining efficacy on clinical outcomes.
ClinicalTrials.gov NCT04976933; https://clinicaltrials.gov/ct2/show/NCT04976933.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39098.
在美国，用药依从性差导致的与药物相关的住院病例占总数的70%，每年造成的医疗保健费用高达1000亿美元。在儿科领域，依从性很大程度上取决于护理人员。在高危造血干细胞移植（HSCT）人群中，由于感染风险，护理人员与孩子被隔离，且必须在家中管理具有挑战性的治疗方案，而他们的时间和支持往往有限。通常用于解决依从性问题的复杂行为干预措施，在这些日常任务的背景下难以实施和管理。最成功的依从性干预措施，进而改善临床结果的措施，包括移动健康（mHealth）提醒方法和对依从性的直接测量。
这是一个分三个阶段的项目，本方案描述的是第二阶段，旨在确定一款mHealth应用程序（BMT4me）的可用性和可行性，该应用程序旨在促进接受HSCT的儿童对免疫抑制剂药物的依从性，并跟踪其症状。
本研究采用迭代收敛混合方法设计，以开发和评估一种依从性数字健康干预措施的可用性和可行性。我们将招募15名接受HSCT的儿科患者的护理人员来完成用户测试。定性和定量数据将被整合，以加强和扩展研究结果。
招募工作于2021年9月开始，目前仍在进行中。共有7名护理人员已登记入组。我们预计2022年秋季完成。我们预计该应用程序会获得较高的可用性评分，并且能更好地了解移植后HSCT家庭所需的该应用程序的独特功能。迄今为止，已登记参与者的可用性评分超过70%。定性访谈的反馈被用于通过添加特定的每周日志、呼叫提供者选项和语音转文本功能来进一步调整该应用程序。
本方案描述了一项混合方法的可用性和可行性研究，以开发并为接受HSCT的儿童的护理人员实施一款智能手机应用程序。该应用程序旨在提高免疫抑制剂的依从性，并跟踪出院后急性期的症状。研究结果将为该应用程序的进一步完善以及一项检验对临床结果疗效的试点随机对照试验的可行性提供信息。
ClinicalTrials.gov NCT04976933；https://clinicaltrials.gov/ct2/show/NCT04976933。
国际注册报告识别码（IRRID）：DERR1-10.2196/39098。
