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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 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.

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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.

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

FieldValue
Enrollment Target 310 participants
Start Date 2025-02-03
Est. Completion 2028-06-30
Phase Phase 2

What the Registry Record Tells You About NCT06290401

The ClinicalTrials.gov registry entry for NCT06290401 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 100-participant average among 17 other Anemia, Sickle Cell trials with a reported enrollment target (210% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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