A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 390
- 试验地点
- 14
- 主要终点
- Connor-Davidson Resilience Scale (CD-RISC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Usual Care
Usual Care arm used as a control
Intervention arm
WE BEAT telemedicine intervention
干预措施: Telemedicine-based resiliency-building intervention (Behavioral)
结局指标
主要结局
Connor-Davidson Resilience Scale (CD-RISC)
时间窗: from baseline to week 5 (immediately post-intervention).
Connor-Davidson Resilience Scale© (CD-RISC©) is a self-reported, unidimensional 5-point Likert scale measuring resilience. Total scores range from 0-40 with higher scores indicating greater resilience. It has been validated for use in children and adolescents across various countries.
次要结局
- Concentration of C-reactive protein (CRP) (biomarker of inflammation)(baseline, week 5, and week 30)
- Connor-Davidson Resilience Scale (CD-RISC)(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(from baseline to week 5, baseline to week 18, baseline to week 30)
- Kessler-6 (K6)(from baseline to week 5, baseline to week 18, baseline to week 30)
- PedsQL, Generic Core and Cardiac Module(from baseline to week 5, baseline to week 18, baseline to week 30)
- Life's Essential 8(from baseline to week 5, baseline to week 18, baseline to week 30)
- Multidimensional Scale of Perceived Social Support(from baseline to week 5, baseline to week 18, baseline to week 30)
- Self-Perceived Health Status(from baseline to week 5, baseline to week 18, baseline to week 30)
- WE BEAT Survey(Intervention Participant Report at Week 5)
- Concentration of cortisone (biomarker of stress)(baseline, week 5, and week 30)
- Concentration of TNF-alpha (biomarker of inflammation)(baseline, week 5, and week 30)
- Concentration of IL-6 (biomarker of inflammation)(baseline, week 5, and week 30)
- Concentration of IL-8 (biomarker of inflammation)(baseline, week 5, and week 30)
- Biomarkers of aging(baseline, week 5, and week 30)