Clinical trial NCT06290401: A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
Official title: A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anemia, Sickle Cell
Keywords: adolescent and young adult (AYA)
self-management
behavioral intervention
sickle cell disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Nemours Children's Health System
name: Emory University
name: Children's Hospital of Philadelphia
First posted: 2024-03-04
Enrollment: 310
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be allocated to SCThrive or SCHealthED (uniform standard care) using a randomized block design for age group (13-17 years of age or 18-21 years of age) with a predefined block size of 4.
Primary purpose: TREATMENT

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.

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).

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.

Primary outcomes:
measure: Patient Activation
timeFrame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Secondary outcomes:
measure: Self-Management Behaviors
timeFrame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
measure: Daily Functioning
timeFrame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
measure: Emergency Room (ER) Visits
timeFrame: 6 months prior to treatment; 6 months post-treatment
measure: Self-Management Skills
timeFrame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
measure: Health-related quality of life
timeFrame: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Health
state: Delaware
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lori E. Crosby, PsyD
role: PRINCIPAL_INVESTIGATOR
References: