Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06290401

Conditions

Anemia, Sickle Cell

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

SCThrive

SCHealthED

Study Details

Brief 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

Anemia, Sickle Cell

Study ID

NCT06290401

Start date

Feb 3, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient of a participating SCD Clinic
  • Confirmed diagnosis of SCD
  • 13-21 years of age

Exclusion Criteria:

  • Another chronic disease (which would complicate measurement of patient activation)
  • Non-English-speaking
  • Cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation.

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

SCThrive

SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.

SCHealthED

Standard of care plus 7 SCD educational text messages to ensure education 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 and Locations

Central contacts

Ama Wilson, MPH

15136365380Ama.Wilson@cchmc.org

Taylor Richardson, BA

Taylor.Richardson2@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Lori Crosby, PsyD

513-636-5380lori.crosby@cchmc.org

Ama Wilson, MPH

513-803-0917ama.wilson@cchmc.org

Principal Investigator:

Lori Crosby, PsyD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • adolescent and young adult (AYA)
  • self-management
  • behavioral intervention
  • sickle cell disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-05-11.