A Socio-ecological Approach for Improving Self-management in Adolescents With SCD (SC-Thrive)

Cincinnati Children's Hospital Medical Center

Status and phase: Not yet enrolling; Phase 2

Conditions: Anemia, Sickle Cell

Treatments: Behavioral: SCThrive; Other: SCHealthED

Study type: Interventional

Funder types: Other

Identifiers

NCT06290401

2023-0671

Details and patient eligibility

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.

Full description

The research team's pilot work demonstrated improved patient activation (knowledge, skills, and self-efficacy) and self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD) compared to a control condition. Further analyses revealed that participants who used the app more frequently showed greater improvements. Thus, this study will maximize the clinical benefit of SCThrive by 1) adding app engagement strategies, 2) conducting a more systematic assessment of barriers including social contributors to health, and 3) integrating ways to address these barriers into the intervention.

Study Aims: The aims are to examine the impact of SCThrive on patient activation (primary outcome; Aim 1) and self-management behaviors, daily functioning, and emergency room visits (secondary outcomes) at post-treatment and follow-up (Aim 2). It is hypothesized that adolescents randomized to SCThrive will have greater improvement in patient activation (primary outcome) compared to those randomized to uniform standard care (control condition). The research team will also explore the relationship between social determinants of health (SDOH)-related barriers (e.g., stigma, access to care) and treatment response (i.e., patient activation and self-management behaviors).

Enrollment: 310 estimated patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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310 participants in 2 patient groups, including a placebo group

Active Treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: SCThrive

Control Condition

Placebo Comparator group

Description:

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.

Treatment:

Other: SCHealthED