Fiallo-Scharer Rosanna, Palta Mari, Chewning Betty A, Wysocki Tim, Wetterneck Tosha B, Cox Elizabeth D
Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee, WI 53266, USA.
Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI 53726, USA; Department of Biostatistics and Medical Informatics, University of Wisconsin School of Medicine and Public Health, Madison, WI 53726, USA.
Contemp Clin Trials. 2017 Jul;58:58-65. doi: 10.1016/j.cct.2017.04.007. Epub 2017 Apr 24.
This article describes the methodology, recruitment, participant characteristics, and sustained, intensive stakeholder engagement for Project ACE (Achieving control, Connecting resources, Empowering families). Project ACE is a randomized controlled trial of children and youth ages 8-16 with type 1 diabetes evaluating the impact of tailored self-management resources on hemoglobin A1c (A1c) and quality of life (QOL). Despite strong evidence that controlling A1c reduces long-term complications, <25% of US youth with type 1 diabetes meet A1c targets. Many interventions are efficacious in improving A1c and QOL for these youth, whose families often struggle with the substantial demands of the treatment regimen. However, most such interventions are ineffective in the real world due to lack of uptake by families and limited healthcare system resources. Project ACE is a multi-site trial designed to improve diabetes outcomes by tailoring existing, evidence-based interventions to meet families' needs and preferences. We hypothesize that this family-centered approach will result in better A1c and QOL than usual care. Project ACE has recruited and randomized 214 eligible 8-16year old youth and their parents. The 9-month intervention consisted of 4 group sessions tailored to families' self-management barriers as identified by a validated instrument. Outcomes including A1c and QOL for parents and youth will be assessed for 1year after the intervention. Stakeholder engagement was used to enhance this trial's recruitment, retention and integration into routine clinical care. Findings will inform implementation and dissemination of family-centered approaches to address self-management barriers.
NCT02024750 Trial Registrar: Clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT02024750.
本文介绍了“ACE项目”（实现控制、连接资源、赋能家庭）的方法、招募情况、参与者特征以及持续且深入的利益相关者参与情况。“ACE项目”是一项针对8至16岁1型糖尿病儿童和青少年的随机对照试验，评估量身定制的自我管理资源对糖化血红蛋白（A1c）和生活质量（QOL）的影响。尽管有充分证据表明控制A1c可减少长期并发症，但美国1型糖尿病青少年中只有不到25%的人达到A1c目标。许多干预措施对改善这些青少年的A1c和QOL有效，但其家庭往往难以应对治疗方案的巨大需求。然而，由于家庭缺乏接受度以及医疗系统资源有限，大多数此类干预措施在现实世界中效果不佳。“ACE项目”是一项多中心试验，旨在通过调整现有的循证干预措施以满足家庭的需求和偏好来改善糖尿病治疗效果。我们假设这种以家庭为中心的方法将比常规护理带来更好的A1c和QOL。“ACE项目”已招募并随机分配了214名符合条件的8至16岁青少年及其父母。为期9个月的干预包括4次根据经过验证的工具确定的家庭自我管理障碍量身定制的小组会议。干预后1年内将评估包括父母和青少年的A1c和QOL在内的结果。利益相关者参与被用于加强该试验的招募、保留以及融入常规临床护理。研究结果将为解决自我管理障碍的以家庭为中心的方法的实施和推广提供参考。
NCT02024750 试验注册机构：Clinicaltrials.gov，https://clinicaltrials.gov/ct2/show/NCT02024750
