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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia, Sickle Cell
• Intervention / Treatment: Behavioral: SCThrive; Other: SCHealthED

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).

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ama Wilson, MPH; Phone Number: 15136365380; Email: Ama.Wilson@cchmc.org
• Study Contact Backup: Name: Taylor Richardson, BA; Email: Taylor.Richardson2@cchmc.org

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Not yet recruiting
      • Nemours Children's Health
      • Contact: Benjamin Bear, MSW; Phone Number: 302-723-9331; Email: benjamin.bear@nemours.org
      • Principal Investigator: Aimee Hildenbrand, PhD
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Not yet recruiting
      • Children's Healthcare of Atlanta
      • Contact: Vontarius Howard; Phone Number: 404-785-3245; Email: Vontarius.Howard@choa.org
      • Principal Investigator: Soumitri Sil, PhD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Lori Crosby, PsyD; Phone Number: 513-636-5380; Email: lori.crosby@cchmc.org
      • Contact: Ama Wilson, MPH; Phone Number: 513-803-0917; Email: ama.wilson@cchmc.org
      • Principal Investigator: Lori Crosby, PsyD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • Children's Hospital of Philadelphia
      • Contact: Polina Poliakova; Phone Number: 267-426-0355; Email: poliakovap@chop.edu
      • Principal Investigator: Lisa Schwartz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: SCThrive; 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.	Other: SCHealthED; Standard of care plus 7 SCD educational text messages to ensure education is uniform across sites; Other Names: Uniform Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation	Self-reported patient activation as measured by the Patient Activation Measure -13 (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progression from being passive with regard to one's health to being proactive: Level 1 (score of 0.0 - 47.0), Level 2 (47.1 - 55.1), Level 3 (55.2 - 72.4), and Level 4 (72.5 - 100). Higher scores indicate more behavioral activation.	baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Management Behaviors	self-reported self-management behaviors as measured by the Transition Readiness Assessment Questionnaire - 6 (TRAQ-6), which is a well-validated 20-item questionnaire that measures the skills needed to manage a chronic condition independently. Items are rated on a 5-point Likert scale of 1 = "No, I do not know how" to 5 = "Yes, I always do this when I need to" and divided into 5 subscales: Managing Medication, Appointment Keeping, Tracking Health Issues, Talking with Providers, and Managing Daily Activities. Overall and subscale scores are calculated by averaging the scores of answered items. Mean scores range from 1 to 5 with higher scores indicating better self-management.	baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Daily Functioning	The Functional Disability Inventory is a self-report measure of limitations in children's physical and psychosocial functioning due to their physical health. The instrument consists of 15 items concerning activity limitations due to "being sick or not feeling well" during the past 2 weeks. Total scores ranging from 0 to 60 are computed by summing the ratings for each of the 15 items on the FDI. Higher scores indicate greater perceived functional disability.	baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Emergency Room (ER) Visits	number of emergency room visits	6 months prior to treatment; 6 months post-treatment
Self-Management Skills	Participants complete the UNC TRxANSITION Scale, an interview administered by trained independent evaluators to measure the skills of youth with chronic conditions. For this study, we will administer 6 of the 10 possible subscales: Type of Chronic Health Condition, Medications, Adherence, Nutrition, Self-Management Skills, and New Health Care Providers. Each item is scored individually as either 1 (adequate knowledge/skill mastery), 0.5 (some knowledge/skill attainment), or 0 (no knowledge/skill attainment). Higher scores indicate better self-management. Subscale scores are calculated by dividing the patient's score by the total possible subscale score. Subscale scores are then combined to create a total score, ranging from 0 to 10, but since we will only use 6 scales, 0 to 6. Total and subscale proportion scores will be used in analyses.	baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Health-related quality of life	Patient report of sickle cell disease (SCD)-specific quality of life (QOL) and pain, as measured by the Pediatric Quality of Life (PedsQL) SCD Module, which assesses several domains of health-related quality of life (HRQOL), including pain impact, fatigue, pain management, emotions, communication, and treatment adherence. Total score only. Scores range from 0 to 100, with higher scores indicating higher HRQOL or higher functioning.	baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Children's Hospital of Philadelphia; Emory University; Nemours Children's Health System
• Investigators: Principal Investigator: Lori E. Crosby, PsyD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: behavioral intervention; self-management; sickle cell disease; adolescent and young adult (AYA)
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell
• Other Study ID Numbers: 2023-0671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only de-identified data will be shared with other researchers. Deidentified data sets will be available on the Open Science Framework.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No