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

Anemia, Sickle Cell Clinical Trial

— SC-Thrive  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290401
• Other study ID #: 2023-0671
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 30, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Ama Wilson, MPH
• Phone: 15136365380
• Email: Ama.Wilson[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 310
• Est. completion date: June 30, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Children's Hospital of Philadelphia, Emory University, Nemours Children's Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Emergency Room (ER) Visits	number of emergency room visits	6 months prior to treatment; 6 months post-treatment
Secondary	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
Secondary	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