A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study

Обзор

The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes. Eligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules/skills introduced in the program will be provided. All participants will complete 4 sets of online surveys and give 3 hair/saliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.

Вмешательства

• Поведенческое Telemedicine-based resiliency-building intervention
  Improving Access and Increasing Resilience through the WE BEAT Well-Being Education Program. The WE BEAT Well-Being Education Program was developed for pediatric patients with heart disease. The evidence-based components of the 5-module WE BEAT intervention are derived from cognitive behavioral theory, stress management and resiliency research, and behavioral intervention science across pediatric populations and adult heart disease. The five WE BEAT modules include: Well-being Education--Introdu

Первичные конечные точки

• Connor-Davidson Resilience Scale (CD-RISC) [Срок оценки: from baseline to week 5 (immediately post-intervention).]

Вторичные конечные точки (12)

• Connor-Davidson Resilience Scale (CD-RISC) [Срок оценки: from baseline to Week 18, from baseline to week 30, from baseline to week 5 (for the subpopulation of participants with moderate to low baseline CD-RISC)]
• NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Scales [Срок оценки: from baseline to week 5, baseline to week 18, baseline to week 30]
• Kessler-6 (K6) [Срок оценки: from baseline to week 5, baseline to week 18, baseline to week 30]
• PedsQL, Generic Core and Cardiac Module [Срок оценки: from baseline to week 5, baseline to week 18, baseline to week 30]
• Life's Essential 8 [Срок оценки: from baseline to week 5, baseline to week 18, baseline to week 30]
• Multidimensional Scale of Perceived Social Support [Срок оценки: from baseline to week 5, baseline to week 18, baseline to week 30]
• Self-Perceived Health Status [Срок оценки: from baseline to week 5, baseline to week 18, baseline to week 30]
• WE BEAT Survey [Срок оценки: Intervention Participant Report at Week 5]
• Concentration of cortisone (biomarker of stress) [Срок оценки: baseline, week 5, and week 30]
• Concentration of C-reactive protein (CRP) (biomarker of inflammation) [Срок оценки: baseline, week 5, and week 30]
• Concentration of TNF-alpha (biomarker of inflammation) [Срок оценки: baseline, week 5, and week 30]
• Concentration of IL-6 (biomarker of inflammation) [Срок оценки: baseline, week 5, and week 30]

Критерии участия

Критерии включения

• Age 12-17 years old
• CHD of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4)
• English or Spanish language proficiency
• Receives cardiology care at a PHN or PHN auxiliary site
• Parent or guardian and participant willing to comply with protocol and provide written/electronic informed consent and assent

Критерии исключения

• CHD of mild or simple complexity (Class I, 2018 AHA/ACC ACHD, Table 4)
• Prior heart transplant to treat CHD
• Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease)
• Cognitive or developmental conditions that limit program participation and/or ability to complete self-reported measures as determined by a primary cardiology clinician
• Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening
• Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 14 центров

• Stanford School of Medicine — Stanford
• Children's Hospital Colorado — Aurora
• Emory University School of Medicine — Atlanta
• University of Kentucky College of Medicine — Lexington
• Boston Children's Hospital — Boston
• University of Michigan Health System — Ann Arbor
• Washington University School of Medicine — St Louis
• Icahn School of Medicine at Mount Sinai — New York
• … и ещё 6 центров

Идентификаторы

NCT: NCT07525843 · 20858 PHN WBC · U24HL172722

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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