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 — BEHAVIORAL
    SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
  • SCHealthED — OTHER
    Standard 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 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.

Primary Outcome Measure

Patient Activation [ Time Frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Nemours Children's HealthWilmingtonDelaware19803
Benjamin Bear, MSW
302-723-9331
Aimee Hildenbrand, PhD (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of AtlantaAtlantaGeorgia30303
Vontarius Howard
404-785-3245
Soumitri Sil, PhD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Lori Crosby, PsyD
513-636-5380
Ama Wilson, MPH
513-803-0917
Lori Crosby, PsyD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Polina Poliakova
267-426-0355
Lisa Schwartz, PhD (PRINCIPAL_INVESTIGATOR)

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