A Socio-ecological Approach for Improving Self-management in Adolescents With SCD

Recruiting · NCT06290401 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati

View the official record on ClinicalTrials.gov →

Sickle cell disease

Interventions studied

SCHealthEDSCThrive

What this trial is about

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.

Who can take part

Age range

13 Years to 21 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

4 locations listed across 4 US states.

Nemours Children's Health - Wilmington, Delaware, United States
Children's Healthcare of Atlanta - Atlanta, Georgia, United States
Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →