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

NCT06290401 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-0671
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 4

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.

Conditions

Anemia, Sickle Cell

Keywords

adolescent and young adult (AYA); self-management; behavioral intervention; sickle cell disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self-Management Behaviors

  baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends

• Daily Functioning

  baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends

• Emergency Room (ER) Visits

  6 months prior to treatment; 6 months post-treatment

• Self-Management Skills

  baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends

• Health-related quality of life

  baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

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

Behavioral: SCThrive

Control Condition

PLACEBO COMPARATOR

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

Interventions

SCThrive BEHAVIORAL

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

Active Treatment

SCHealthED OTHER

Standard of care plus 7 SCD educational text messages to ensure education is uniform across sites

Also known as: Uniform Standard Care

Control Condition

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient of a participating SCD Clinic
• Confirmed diagnosis of SCD
• years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Nemours Children's Health System: collaborator
• Emory University: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (4)

Nemours Children's Health

Wilmington, Delaware, 19803, United States

NOT YET RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30303, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lori E. Crosby, PsyD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ama Wilson, MPH

CONTACT

15136365380; Ama.Wilson@cchmc.org

Taylor Richardson, BA

CONTACT

Taylor.Richardson2@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and Outcomes assessors will not know the condition to which participants have been randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 4, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)