Investigating Pathways to Medication (Non)Adherence in Adolescent Solid Organ Transplant Patients

调查青少年实体器官移植患者药物（非）依从性的途径

• 批准号: 9758859
• 负责人: Sarah Elizabeth Duncan-Park
• 金额: $ 3.41万
• 依托单位: FORDHAM UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-28 至 2021-04-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9758859
• 关键词: Address; Adherence; Adolescence; Adolescent; Age; Behavior; Behavioral; Biological Markers; Categories; Cessation of life; Characteristics; Child; Childhood; Chronically Ill; Clinical; Clinical Trials; Collaborations; Data; Data Analyses; Development; Education; Educational Status; Educational process of instructing; Enrollment; Ensure; Family Characteristics; Feedback; Fellowship; Goals; Graft Rejection; Health; Health Promotion; Hospitalization; Immunosuppression; Immunosuppressive Agents; Individual; Institution; Insurance Coverage; Intervention; Intervention Studies; Intervention Trial; Knowledge; Lead; Manuals; Marital Status; Measures; Medical; Mission; Monitor; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; New York City; Organ; Organ Transplantation; Outcome; Parents; Participant; Pathway interactions; Patient Noncompliance; Patients; Pattern; Pharmaceutical Preparations; Population; Preparation; Prevalence; Primary Prevention; Protocols documentation; Psychosocial Factor; Publishing; Randomized Controlled Trials; Reporting; Research; Risk; Risk Factors; Sample Size; Sampling; Science; Secondary Prevention; Severities; Site; Solid; Specific qualifier value; Statistical Methods; Stratification; Symptoms; Time; Training; Training Activity; Transplant Recipients; Transplantation; United States; Universities; Writing; base; behavioral health; cohort; compliance behavior; depressive symptoms; design; follow-up; graft failure; health management; improved; indexing; innovation; insight; liver transplantation; medical schools; medication compliance; medication nonadherence; mortality; novel; novel strategies; post-transplant; post-traumatic stress; prospective; protective factors; psychosocial; recruit; secondary analysis; sex; stress symptom; therapy development; transplant centers; transplantation medicine

PROJECT SUMMARY/ABSTRACT Immunosuppressive (IS) medication nonadherence is a health management problem with dire consequences for solid organ transplant (SOT) recipients, placing them at increased risk for hospitalization (1,2), rejection (2–4), graft loss, and mortality (1,4–6). The risk for nonadherence peaks in adolescence (7–10), making this developmental stage a critical time for intervention. Significant research efforts have been made to improve adherence; yet, published interventions have generally not demonstrated improved clinical outcomes (11). To address this gap, this application proposes a secondary analysis of data collected through the multi- site Clinical Trials in Organ Transplantation in Children consortium’s Protocol 11 (CTOT-C-11): “Prevalence & Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients.” CTOT-C-11 is the largest currently established cohort of adolescent SOT recipients. The primary aim of the proposed study is to compare demographic and psychosocial profiles of adherent (A), mildly nonadherent (MA), and severely nonadherent (SA) adolescent SOT recipients and identify patterns of risk to create a targeted adherence intervention and treatment manual. Adherence will be measured using the Medication Level Variability Index (MLVI), a robust biomarker of IS adherence. It is hypothesized that patient/transplant characteristics (PTSS, depressive symptoms, sex, age, transplant type, insurance status) and parental factors (PTSS, education, marital status) will have differential associations and interconnections with the adherence levels (A, MA, SA). It is also hypothesized that degree of symptom severity or characteristic level will predict patients’ adherence class (e.g. MA patients will have higher PTSS compared to A patients, but lower PTSS compared to SA patients). Exploratory analyses will investigate how the profiles of A, MA, and SA patients are related to transplant outcomes (i.e. rejection/graft failure as defined by CTOT-C-11). This project will culminate in the development of an intervention and treatment manual designed to improve IS adherence. The analyses described in the primary aim will be used to target the intervention components to specific levels of adherence (A, MA, and SA) – an approach that has not been tried in this population. This proposed project seeks to advance the understanding of nonadherence behavior in order to strengthen the interventions available to clinicians and thereby promote the health of SOT recipients and chronically ill populations more broadly. The proposed fellowship training plan would provide the applicant in-depth training in correspondence analysis [an advanced statistical method for categorical data (12)], intervention development, and treatment manual writing. This training will take place at Fordham University, a research institution in New York City, and Icahn School of Medicine at Mount Sinai, an academic medical teaching facility also in NYC. Both will provide substantial support for the proposed training activities as well as professional development opportunities to prepare the applicant to become a successful contributor to intervention science and behavioral health.

项目摘要/摘要 免疫抑制(IS)药物不依从性是一个可怕的健康管理问题 实体器官移植(SOT)接受者的后果，使他们住院的风险增加 (1，2)、排斥(2-4)、移植物丢失和死亡率(1，4-6)。不坚持的风险在青春期(7-10岁)最高， 使这一发展阶段成为干预的关键时期。已经做出了重大的研究努力来 改善依从性；然而，已发表的干预措施一般没有显示出改善的临床结果 (11)。为了解决这一差距，该应用程序建议对通过多个 儿童器官移植现场临床试验11(CTOT-C-11)：“流行率和 青少年实体器官移植受者创伤后应激症状(PTSS)的相关性 CTOT-C-11是目前建立的最大的青少年SOT接受者队列。该计划的主要目标是 建议的研究是比较依从者(A)、轻度不依从者(A)的人口统计学和心理社会特征 (MA)和严重不遵守(SA)的青少年SOT接受者，并确定风险模式以创建 有针对性的坚持干预和治疗手册。依从性将使用药物来衡量 水平变异性指数(MLVI)，一个强有力的IS依从性生物标志物。据推测病人/移植 特征(PTSS、抑郁症状、性别、年龄、移植类型、保险状况)和父母因素 (PTSS、教育程度、婚姻状况)将与遵从性有不同的关联和相互联系 级别(A、MA、SA)。还假设症状的严重程度或特征级别将预测 患者依从性等级(例如，与A患者相比，MA患者的PTSS较高，但PTSS较低 与SA患者相比)。探索性分析将调查A、MA和SA患者的概况 与移植结果有关(即CTOT-C-11定义的排斥反应/移植失败)。这个项目将达到顶峰 在制定干预和治疗手册的过程中，旨在提高依从性。这些分析 主要目标中描述的将用于将干预组件定向到特定的遵守程度 (A、MA和SA)--这是一种尚未在该人群中尝试的方法。这项拟议的项目旨在 促进对不遵守行为的理解，以加强可用于 临床医生，从而在更广泛的范围内促进SOT接受者和慢性病患者的健康。 拟议的研究金培训计划将为申请者提供深入的通信培训。 分析[分类数据的高级统计方法(12)]、干预发展和治疗 手工书写。这项培训将在纽约市的研究机构福特汉姆大学进行， 位于西奈山的伊坎医学院，这也是纽约市的一个学术医学教学设施。两者都将提供 为拟议的培训活动以及职业发展机会提供大量支持，以 让申请者做好准备，成为干预科学和行为健康的成功贡献者。