A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
Part of paid clinical trials in Wilmington, Delaware.
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Study ID
- NCT06290401
- Status
- Recruiting
Conditions
- Anemia, Sickle Cell
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- SCThrive — BEHAVIORALSCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
- SCHealthED — OTHERStandard of care plus 7 SCD educational text messages to ensure education is uniform across sites
Study Details
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.
Key Dates
- Start date
- Feb 3, 2025
- Status verified
- May 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 310 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active TreatmentSCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
- Placebo Comparator: Control ConditionParticipants randomized to SCHealthED will receive usual care plus 7 text messages consisting of SCD educational facts to ensure the care is uniform across sites.
Primary Outcome Measure
Patient Activation [ Time Frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends ]
Central Contacts
- Ama Wilson, MPH15136365380
- Taylor Richardson, BA
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nemours Children's Health | Wilmington | Delaware | 19803 | Aimee Hildenbrand, PhD (PRINCIPAL_INVESTIGATOR) |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30303 | Soumitri Sil, PhD (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Lori Crosby, PsyD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Lisa Schwartz, PhD (PRINCIPAL_INVESTIGATOR) |
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