Self-Management for Youth Living with Sickle Cell Disease (SMYLS): A study protocol for a multisite randomized...

Adolescents and young adults (AYA) with sickle cell disease (SCD) encounter adverse health events during transition to adult care. While AYA with SCD face complex barriers to care, negative outcomes can be mitigated by the development of self-management behaviors. Self-Management for Youth Living with Sickle Cell Disease (SMYLS) is an application designed to improve SCD specific self-management, with promising results from feasibility studies. This paper describes the next stage of SMYLS, a multisite, hybrid type 1 effectiveness-implementation randomized controlled trial. Trial aims are to evaluate the effectiveness of the mHealth application, including the role of patient activation; assess potential for wide-scale implementation; and explore the impact of socioenvironmental and psychosocial factors on outcomes. There will be 272 AYA with SCD and their caregivers enrolled and randomized to control or intervention arm (1:1) after assessing activation level. The intervention arm will receive usual care and be encouraged to use the application daily for an initial intervention period and a later "booster" period, while the control arm will receive usual care plus a version of the application with SCD educational materials. Study aims will be evaluated using mixed methods (participant surveys at 1, 3, 6, 9, and 12 months and interviews with participants and providers/clinic administrators post-intervention). The SMYLS intervention has the potential to inform widescale adoption of a self-management intervention for AYA with SCD. The results may have broader applicability for conducting trials among youth with chronic illnesses facing similar barriers to care and for studying engagement in mHealth self-management interventions. Clinical trial registration number. NCT06035939.