Smaldone Arlene, Findley Sally, Bakken Suzanne, Matiz L Adriana, Rosenthal Susan L, Jia Haomiao, Matos Sergio, Manwani Deepa, Green Nancy S
Columbia University School of Nursing, New York, NY, United States; College of Dental Medicine, Columbia University Medical Center, New York, NY, United States.
Mailman School of Public Health, New York, NY, United States.
Contemp Clin Trials. 2016 Jul;49:134-42. doi: 10.1016/j.cct.2016.06.004. Epub 2016 Jun 17.
Community health workers (CHW) are increasingly recognized as a strategy to improve health outcomes for the underserved with chronic diseases but has not been formally explored in adolescents with sickle cell disease (SCD). SCD primarily affects African American, Hispanic and other traditionally underserved populations. Hydroxyurea (HU), an oral, once-daily medication, is the only approved therapeutic drug for sickle cell disease and markedly reduces symptoms, morbidity and mortality and improves quality of life largely by increasing hemoglobin F blood levels. This paper presents the rationale, study design and protocol for an open label randomized controlled trial to improve parent-youth partnerships in self-management and medication adherence to HU in adolescents with SCD.
METHODS/DESIGN: A CHW intervention augmented by text messaging was designed for adolescents with SCD ages 10-18years and their parents to improve daily HU adherence. Thirty adolescent parent dyads will be randomized with 2:1 intervention group allocation. Intervention dyads will establish a relationship with a culturally aligned CHW to identify barriers to HU use, identify cues to build a habit, and develop a dyad partnership to improve daily HU adherence and achieve their individualized "personal best" hemoglobin F target. Intervention feasibility, acceptability and efficacy will be assessed via a 2-site trial. Outcomes of interest are HU adherence, dyad self-management communication, quality of life, and resource use.
Despite known benefits, poor HU adherence is common. If feasible and acceptable, the proposed intervention may improve health of underserved adolescents with SCD by enhancing long-term HU adherence.
NCT02029742.
社区卫生工作者（CHW）日益被视为一种改善慢性病患者健康状况的策略，但尚未在患有镰状细胞病（SCD）的青少年中进行正式探索。SCD主要影响非裔美国人、西班牙裔和其他传统上服务不足的人群。羟基脲（HU）是一种口服的每日一次用药，是唯一被批准用于镰状细胞病的治疗药物，它能显著减轻症状、发病率和死亡率，并通过提高血液中胎儿血红蛋白水平在很大程度上改善生活质量。本文介绍了一项开放标签随机对照试验的基本原理、研究设计和方案，该试验旨在改善患有SCD的青少年在自我管理和HU药物依从性方面的亲子伙伴关系。
方法/设计：设计了一种通过短信增强的CHW干预措施，用于10至18岁患有SCD的青少年及其父母，以提高他们每日对HU的依从性。30对青少年亲子将按2:1的比例随机分配到干预组。干预组的亲子将与一名文化背景相符的CHW建立关系，以识别使用HU的障碍、确定养成习惯的提示，并建立亲子伙伴关系以提高每日对HU的依从性，并实现他们个性化的“个人最佳”胎儿血红蛋白目标。将通过一项在两个地点进行的试验评估干预措施的可行性、可接受性和有效性。感兴趣的结果包括HU依从性、亲子自我管理沟通、生活质量和资源利用情况。
尽管已知HU有诸多益处，但药物依从性差的情况很常见。如果所提议的干预措施可行且可接受，那么它可能通过增强长期的HU依从性来改善患有SCD的服务不足青少年的健康状况。
NCT02029742。
