NCT06035939

SMYLS Multi-site Trial

Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 14 Years – 21 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms.

Detailed description

The purpose of this study is to test the effectiveness of and identify barriers and facilitators to the implementation of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD). Specifically, the investigators propose to determine the effect of the intervention on the primary outcome of self-management behaviors and the secondary outcomes of quality of life, transition readiness, healthcare utilization, and pain interference. In addition, the investigators will explore how patient activation moderates development of self-management behaviors and systemic, structural, and social variables that moderate relationships between patient activation, the primary outcome, and secondary outcomes.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
BEHAVIORAL	Voice Crisis Alert V2	The mHealth self-management intervention consists of the following components: 1) condition-specific electronic educational materials; 2) pain/symptom monitoring and tracking; 3) health history information documentation; 4) medication tracking; 5) secure messaging with a provider; 6) functioning monitoring and tracking; and 7) transmission of health information (graphs with recorded pain and functioning histories) to a provider.
BEHAVIORAL	Electronic educational materials	The control arm will receive enhanced usual care, which will consist of usual educational materials distributed at the clinic plus a version of the intervention (Voice Crisis Alert V2) that only includes the electronic educational materials.

Timeline

• Start date: 2024-04-04
• Primary completion: 2027-07-31
• Completion: 2028-01-31
• First posted: 2023-09-13
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States