NCT06290401

A Socio-ecological Approach for Improving Self-management in Adolescents With SCD

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 13 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics. The main question\[s\]it aims to answer are: * Does SCThrive improve patient activation? * Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits? * Are any improvements maintained 3 months after treatment? Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive). Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.

Detailed description

The research team's pilot work demonstrated improved patient activation (knowledge, skills, and self-efficacy) and self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD) compared to a control condition. Further analyses revealed that participants who used the app more frequently showed greater improvements. Thus, this study will maximize the clinical benefit of SCThrive by 1) adding app engagement strategies, 2) conducting a more systematic assessment of barriers including social contributors to health, and 3) integrating ways to address these barriers into the intervention. Study Aims: The aims are to examine the impact of SCThrive on patient activation (primary outcome; Aim 1) and self-management behaviors, daily functioning, and emergency room visits (secondary outcomes) at post-treatment and follow-up (Aim 2). It is hypothesized that adolescents randomized to SCThrive will have greater improvement in patient activation (primary outcome) compared to those randomized to uniform standard care (control condition). The research team will also explore the relationship between social determinants of health (SDOH)-related barriers (e.g., stigma, access to care) and treatment response (i.e., patient activation and self-management behaviors).

Conditions

• Anemia, Sickle Cell

Interventions

Type	Name	Description
BEHAVIORAL	SCThrive	SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
OTHER	SCHealthED	Standard of care plus 7 SCD educational text messages to ensure education is uniform across sites

Timeline

• Start date: 2025-02-03
• Primary completion: 2028-01-31
• Completion: 2028-06-30
• First posted: 2024-03-04
• Last updated: 2025-03-04

Locations

4 sites across 1 country: United States