目标:目前,近90%的先天性心脏病(CHD)患者在相对良好的健康状况下成年。已经出现了结构化的过渡计划,以支持青少年和年轻人过渡到成人护理结构,提高自主性,并限制医疗保健破裂。TRANSITION-CHD随机对照试验旨在评估过渡计划对青少年和年轻冠心病患者健康相关生活质量(HRQoL)的影响。
方法:从2017年1月到2020年2月,200名冠心病患者,13-25岁,被登记在一个潜在的,控制,多中心研究,随机分为两个平衡组(过渡方案与护理标准)。主要结果是基线和12个月随访之间PedsQL自我报告的HRQoL评分的变化,使用意向治疗分析。次要结果是疾病知识的变化,身体健康(心肺健康,身体活动),和心理健康(焦虑,抑郁症)。
结果:过渡组和对照组的HRQoL变化显着不同(平均差=3.03,95%置信区间(CI)=[0.08;5.98];p=.044;效应大小=0.30),支持干预组。在自我报告的心理社会HRQoL中也观察到显着增加(平均差异=3.33,95%CI=[0.01;6.64];p=0.049;效应大小=0.29),在代理报告的物理HRQoL中(平均差异=9.18,95%CI=[1.86;16.51];p=0.015;效应大小=0.53),和疾病知识(平均差异=3.13,95%CI=[1.54;4.72];p<.001;效应大小=0.64)。
结论:TRANSITION-CHD计划改善了青少年和年轻冠心病患者的HRQoL和疾病知识,支持儿科和先天性心脏病学类似预防性干预措施的推广和系统化。
OBJECTIVE: Currently, nearly 90% of patients with congenital heart disease (CHD) reach adulthood in relatively good health. Structured transition programs have emerged to support adolescents and young adults in transitioning to adult care structures, improve their autonomy, and limit healthcare ruptures. The TRANSITION-CHD randomized controlled trial aimed to assess the impact of a transition program on health-related quality of life (HRQoL) in adolescents and young adults with CHD.
METHODS: From January 2017 to February 2020, 200 subjects with a CHD, aged 13-25 years, were enrolled in a prospective, controlled, multicenter study and randomized in two balanced groups (transition program vs. standard of care). The primary outcome was the change in PedsQL self-reported HRQoL score between baseline and 12-month follow-up, using an intention-to-treat analysis. The secondary outcomes were the change in disease knowledge, physical health (cardiopulmonary fitness, physical activity), and mental health (anxiety, depression).
RESULTS: The change in HRQoL differed significantly between the transition group and the control group (mean difference = 3.03, 95% confidence interval (CI) = [0.08; 5.98]; p = .044; effect size = 0.30), in favor of the intervention group. A significant increase was also observed in the self-reported psychosocial HRQoL (mean difference = 3.33, 95% CI = [0.01; 6.64]; p = .049; effect size = 0.29), in the proxy-reported physical HRQoL (mean difference = 9.18, 95% CI = [1.86; 16.51]; p = .015; effect size = 0.53), and in disease knowledge (mean difference = 3.13, 95% CI = [1.54; 4.72]; p < .001; effect size = 0.64).
CONCLUSIONS: The TRANSITION-CHD program improved HRQoL and disease knowledge in adolescents and young adults with CHD, supporting the generalization and systematization of similar preventive interventions in pediatric and congenital cardiology.