Improving Adherence in Adolescents and Young Adultswith Bipolar Disorder

提高双相情感障碍青少年和年轻人的依从性

基本信息

批准号：
10172981
负责人：
Melissa P Delbello
金额：
$ 24.72万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-08 至 2023-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10172981
关键词：
Academic Medical Centers Address Adherence Adolescence Adolescent Adolescent Development Adolescent and Young Adult Adult Age Alcohol consumption Behavior Behavior Therapy Bipolar Disorder Caregivers Characteristics Clinical Clinical Treatment Communication Conflict (Psychology)Custom Data Development Evidence based intervention Family Feedback Focus Groups Foundations Funding Goals Health Health Personnel Homelessness Hospitalization Imprisonment Individual Intervention Knowledge Measures Mediating Methodology Monitor Neurobiology Occupational Outcome Patients Pharmaceutical Preparations Pharmacotherapy Phase Process Provider Questionnaires Randomized Controlled Trials Recovery Relapse Research Personnel Risk Behaviors Risk Factors Risk-Taking Self Management Standardization Statistical Data Interpretation Subgroup Supervision Symptoms Tablets Testing Time United States National Institutes of Health Universities Vulnerable Populations base cognitive interview critical developmental period effectiveness trial efficacy trial emerging adult empowered experience feasibility testing follow-up health related quality of life high risk high risk population high-risk adolescents improved innovation medication compliance modifiable risk mortality patient oriented prevent preventive intervention primary outcome psychiatric symptom psychoeducational response secondary outcome service intervention skills social substance use suicidal risk therapy design treatment as usual trial design

项目摘要

PROJECT SUMMARY The most common onset of bipolar disorder (BD) is during late adolescence and early adulthood. While pharmacotherapy is effective for BD symptoms in adolescents and young adults (AYA), poor adherence occurs in more than 65% of AYAs and is associated with low rates of recovery, high rates of relapse and a 5.2 fold increase in suicide risk. Poor adherence is a critical yet modifiable risk factor of poor outcomes in AYAs with BD. AYAs are an ideal BD subgroup to target and test adherence interventions given the potential impact of enhanced adherence on social, educational and occupational goals during this critical developmental period which can lay the foundation for lifelong BD self-management skills. To date, there are no interventions that specifically target adherence in AYAs with BD. This R34 proposal, written in response to RFA-MH-18-706, Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions will modify and test in AYAs with BD, an effective customized adherence enhancement (CAE) intervention developed for adults with BD by the investigative team. CAE is a brief, practical adherence promotion intervention that is highly generalizable to real-word clinical settings. In adults, CAE improves adherence significantly more than a rigorous BD-specific educational control. The investigative team is based in two academic medical centers (Case Western Reserve University/CWRU and University of Cincinnati/UC) led by two NIH-funded PIs with complementary strengths. The proposed 3-phase project will identify relevant characteristics of AYAs and needed refinements to CAE (Phase 1) and standardize the intervention using iterative refinements based on patient feedback (Phase 2). Phases 1 and 2 will be completed over a 12-month time-period. In Phase 3 (months 13-36) we will test the feasibility, acceptability and preliminary efficacy of the adapted approach using a randomized controlled trial (RCT) design in a high-risk, high-need group: AYAs ages 16-21 with BD who are poorly adherent with prescribed BD medications. The overall hypothesis is that CAE for poorly adherent AYAs with BD (CAE-AYA) will be associated with improved adherence at 6-month follow-up compared to enhanced treatment as usual (ETAU). The primary outcome will be change from baseline in the Tablets Routine Questionnaire (TRQ) and electronic adherence monitoring (SimpleMed boxes). Secondary outcomes will evaluate change in psychiatric symptoms and health- related quality of life. Additional analysis will examine the posited mechanisms of adherence change in BD AYAs as it relates to the adherence barriers of inadequate bipolar knowledge, poor communication with clinicians and family, unstable medication routines and substance use/risky behaviors. If proven effective, the proposed trial will pave the way for a rigorous efficacy trial of CAE-AYA.

项目概要双相情感障碍 (BD) 最常见的发病时间是青春期末期和成年早期。尽管药物治疗对青少年和年轻人 (AYA) 的 BD 症状有效，但依从性较差超过 65% 的 AYA 中存在这种情况，并且与低恢复率、高复发率和 5.2 倍相关自杀风险增加。依从性差是 BD 患者结果不佳的一个关键但可改变的风险因素。鉴于增强的潜在影响，AYA 是一个理想的 BD 亚组，用于瞄准和测试依从性干预措施在这个关键的发展时期坚持社会、教育和职业目标，可以奠定终身 BD 自我管理技能的基础。迄今为止，还没有专门针对遵守 AYA 和 BD。此 R34 提案是为了回应 RFA-MH-18-706“治疗试点有效性试验”而编写的，预防和服务干预将在 AYA 中与 BD 进行修改和测试，这是一种有效的定制依从性调查小组为患有 BD 的成人开发了增强 (CAE) 干预措施。 CAE 是一个简短、实用的依从性促进干预措施高度适用于真实的临床环境。在成人中，CAE 比严格的 BD 特定教育控制更能显着提高依从性。调查组位于两个学术医疗中心（凯斯西储大学/CWRU 和大学辛辛那提/加州大学）由两位 NIH 资助的 PI 领导，优势互补。拟议的三阶段项目将确定 AYA 的相关特征以及 CAE 所需的改进（第 1 阶段）并根据患者反馈使用迭代改进来标准化干预（第 2 阶段）。第一阶段和第二阶段将在 12 个月内完成。在第 3 阶段（第 13-36 个月），我们将测试使用随机对照试验 (RCT) 调整方法的可行性、可接受性和初步功效针对高风险、高需求群体的设计：16-21 岁患有 BD 且不太遵守规定 BD 的 AYA 药物。总体假设是，对于 BD 依从性差的 AYA (CAE-AYA)，CAE 将与与常规强化治疗 (ETAU) 相比，6 个月随访时的依从性有所提高。初级结果将相对于平板电脑常规问卷 (TRQ) 和电子依从性的基线发生变化监测（SimpleMed 盒）。次要结局将评估精神症状和健康状况的变化相关的生活质量。额外的分析将检查 BD AYA 依从性变化的假设机制因为它与双相情感障碍知识不足、与临床医生沟通不畅以及家庭、不稳定的用药习惯和药物使用/危险行为。如果证明有效，拟议的试验将为 CAE-AYA 的严格疗效试验铺平道路。