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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 21
Healthy Volunteers: f
View:

• Patient of a participating SCD Clinic

• Confirmed diagnosis of SCD

• 13-21 years of age

Locations
United States
Delaware
Nemours Children's Health
NOT_YET_RECRUITING
Wilmington
Georgia
Children's Healthcare of Atlanta
NOT_YET_RECRUITING
Atlanta
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
Contact Information
Primary
Ama Wilson, MPH
Ama.Wilson@cchmc.org
15136365380
Backup
Taylor Richardson, BA
Taylor.Richardson2@cchmc.org
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 310
Treatments
Active_comparator: Active Treatment
SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
Placebo_comparator: Control Condition
Participants randomized to SCHealthED will receive usual care plus 7 text messages consisting of SCD educational facts to ensure the care is uniform across sites.
Sponsors
Collaborators: Nemours Children's Health System, Emory University, Children's Hospital of Philadelphia
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov