Belton Tanisha D, Steinway Caren M, Teng Olivia, Shults Justine, Barakat Lamia P, Aygun Banu, Appiah-Kubi Abena, Crosby Lori E, Niss Omar, Andemariam Biree, Schwartz Lisa A, Luma Samantha, Smith Kyle A, Johnson Tracey B, Rubin David M, Smith-Whitley Kim M, Jan Sophia
PolicyLab, Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
Department of Pediatrics, Northwell Health, New Hyde Park, NY, United States.
JMIR Res Protoc. 2025 Sep 4;14:e69239. doi: 10.2196/69239.
Transitioning from pediatric to adult sickle cell disease (SCD) care is challenging for emerging adults (aged 17-25 years). This period is marked by a 7-fold increase in mortality rates and has the highest rates of hospitalizations, emergency room visits, and hospital readmissions compared with children living with SCD. These challenges are exacerbated by fragmented care coordination, difficulty navigating adult health care systems, and increased self-management responsibilities.
This study aims to compare the effectiveness of 2 interventions designed to support emerging adults living with SCD during this transition: a mobile health (mHealth) app and community health worker (CHW) support to standard care.
The Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care (COMETS) trial is an ongoing multicenter, 3-arm, open-label randomized controlled trial; 375 emerging adults (aged 17-25 years) are being enrolled and randomized 1:1:1 to (1) a 6-month CHW intervention focused on self-management skills, symptom tracking, care coordination, and transition planning; (2) a 6-month mHealth self-management program (enhanced iManage application) with tailored SMS text messaging (THRIVE [Texting Health-Related Resources to Inform, Motivate, and Engage] 2.0); or (3) enhanced usual care (control). Participants are followed for 18 months. The primary outcome is the change in self-reported health-related quality of life assessed using the PedsQL SCD module. Secondary outcomes include acute care use (hospitalizations and emergency department visits), patient activation, self-management behavior, and successful transfer to adult hematology care.
The institutional review board at Children's Hospital of Philadelphia approved this study in June 2018. Recruitment began in January 2019 and ended in December 2022; we completed data collection in November 2024. We have enrolled a total of 405 participants.
This trial addresses a critical gap in transition intervention research for young adults with SCD. It will provide evidence on the comparative effectiveness of 2 promising interventions (CHW and mHealth) and inform the development of scalable and sustainable transition support programs. Findings will have implications for improving health-related quality of life, reducing acute care use, and promoting successful transition to adult-centered SCD care for this vulnerable population.
ClinicalTrials.gov NCT03648710; https://clinicaltrials.gov/study/NCT03648710.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/69239.
对于青少年（17 - 25岁）而言，从儿科镰状细胞病（SCD）护理过渡到成人SCD护理具有挑战性。这一时期的死亡率增长了7倍，与患有SCD的儿童相比，住院率、急诊就诊率和再住院率最高。护理协调碎片化、难以适应成人医疗系统以及自我管理责任增加，使这些挑战更加严峻。
本研究旨在比较两种旨在支持青少年SCD患者在这一过渡阶段的干预措施的有效性：一款移动健康（mHealth）应用程序和社区卫生工作者（CHW）支持与标准护理。
青少年镰状细胞病护理过渡的社区卫生工作者与移动健康（COMETS）试验是一项正在进行的多中心、三臂、开放标签随机对照试验；375名青少年（17 - 25岁）正在入组，并按1:1:1随机分为（1）为期6个月的CHW干预，重点是自我管理技能、症状跟踪、护理协调和过渡计划；（2）为期6个月的mHealth自我管理计划（增强版iManage应用程序）及定制短信（THRIVE [发送与健康相关资源以提供信息、激励和参与] 2.0）；或（3）强化常规护理（对照组）。对参与者进行18个月的随访。主要结局是使用儿童生活质量量表SCD模块评估的自我报告的健康相关生活质量的变化。次要结局包括急性护理使用情况（住院和急诊就诊）、患者激活、自我管理行为以及成功转至成人血液科护理。
费城儿童医院的机构审查委员会于2018年6月批准了本研究。招募工作于2019年1月开始，2022年12月结束；我们于2024年11月完成数据收集。我们共招募了405名参与者。
本试验填补了青少年SCD患者过渡干预研究的关键空白。它将提供关于两种有前景的干预措施（CHW和mHealth）的比较有效性的证据，并为可扩展和可持续的过渡支持计划的制定提供信息。研究结果将对改善健康相关生活质量、减少急性护理使用以及促进这一弱势群体成功过渡到以成人为中心的SCD护理产生影响。
ClinicalTrials.gov NCT03648710；https://clinicaltrials.gov/study/NCT03648710。
国际注册报告识别码（IRRID）：DERR1-10.2196/69239。
