A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCThrive, SCHealthED.
- Who it may be relevant to
- Registry conditions: Anemia, Sickle Cell. Basic parameters: 13 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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).
Interventions
- Behavioral SCThrive
SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app. - Other SCHealthED
Standard of care plus 7 SCD educational text messages to ensure education is uniform across sites
Primary outcome measures
- Patient Activation [Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
Secondary outcome measures (5)
- Self-Management Behaviors [Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
- Daily Functioning [Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
- Emergency Room (ER) Visits [Time frame: 6 months prior to treatment; 6 months post-treatment]
- Self-Management Skills [Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
- Health-related quality of life [Time frame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Nemours Children's Health — Wilmington
- Children's Healthcare of Atlanta — Atlanta
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Children's Hospital of Philadelphia — Philadelphia
Identifiers
NCT: NCT06290401 · 2023-0671