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NCT06290401 · ClinicalTrials.gov registry record · Phase 2
A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
A Phase 2 study of Anemia, Sickle Cell, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 310
- Enrollment target
- 4
- Study locations
NCT06290401: Recruiting Phase 2 study of Anemia, Sickle Cell, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT06290401 is a Phase 2 study of Anemia, Sickle Cell that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 310 participants, above the 100-participant average among 17 other Anemia, Sickle Cell trials with a reported enrollment target (210% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06290401, a Phase 2 study of Anemia, Sickle Cell, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 310 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Self-reported patient activation as measured by the Patient Activation Measure -13 (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progressi
Conditions Studied
Interventions
- BEHAVIORAL SCThrive
- OTHER SCHealthED
Study Locations (4)
Delaware
- Nemours Children's Health - Wilmington
Georgia
- Children's Healthcare of Atlanta - Atlanta
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2025-02-03 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What NCT06290401 shows while recruiting
NCT06290401 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 17 other Anemia, Sickle Cell trials with a reported enrollment target (210% higher).
The record links to 1 condition, with Anemia, Sickle Cell appearing as the primary indexed condition, and to 2 interventions - of which SCThrive is the first listed.
NCT06290401 reports a single indexed study location in Delaware, Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT06290401 about?
NCT06290401 is a clinical study titled "A Socio-ecological Approach for Improving Self-management in Adolescents With SCD". 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 car...
What is the current status of trial NCT06290401?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 310 participants. The study started on 2025-02-03. Estimated completion is 2028-06-30.
What conditions does trial NCT06290401 study?
This clinical trial studies the following conditions: Anemia, Sickle Cell.
What interventions are being tested in trial NCT06290401?
The interventions under investigation include: SCThrive (BEHAVIORAL), SCHealthED (OTHER).
Who is sponsoring clinical trial NCT06290401?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06290401 being conducted?
This trial has 4 study locations across Delaware, Georgia, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06290401's enrollment target sits among peer trials
310 1st of 17 higher than 17 of 17 other Anemia, Sickle Cell trials
participants (enrollment target), bucketed by value
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