Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 3, 2024
Date Accepted: Jun 10, 2025
Community Health Workers and Mobile Health for Improving Transition to Adult Sickle Cell Disease Care (COMETS Trial): Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Transitioning from pediatric to adult sickle cell disease (SCD) care is challenging for emerging adults (17-25 years old). This period is marked by a seven-fold increase in mortality rates, and has the highest rates of hospitalizations, emergency room visits, and hospital readmissions compared to children living with SCD. These challenges are exacerbated by fragmented care coordination, difficulty navigating adult healthcare systems, and increased self-management responsibilities.
Objective:
This study aims to compare the effectiveness of two interventions designed to support emerging adults living with SCD during this transition: a mobile health (mHealth) application and community health worker (CHW) support to standard care.
Methods:
The Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care (COMETS Trial) is an ongoing multicenter, three-arm, open-label randomized controlled trial (RCT); 375 emerging adults (17 to 25 years old) 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 texting (THRIVE 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 (HRQOL) assessed using the PedsQL Sickle Cell Disease Module. Secondary outcomes include acute care utilization (hospitalizations, ED visits), patient activation, self-management behavior, and successful transfer to adult hematology care.
Results:
The Institutional Review Board (IRB) at Children’s Hospital of Philadelphia approved this study in June 2018. We have enrolled a total of 405 participants.
Conclusions:
This trial addresses a critical gap in transition intervention research for young adults with SCD. It will provide evidence on the comparative effectiveness of two promising interventions (CHW and mHealth) and inform the development of scalable and sustainable transition support programs. Findings will have implications for improving HRQOL, reducing acute care utilization, and promoting successful transition to adult-centered SCD care for this vulnerable population. Clinical Trial: ClinicalTrials.gov NCT03648710: https://clinicaltrials.gov/study/NCT034648710
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