Addressing Challenges in Schizophrenia Research

应对精神分裂症研究的挑战

• 批准号: 6788858
• 负责人: THOMAS SCOTT STROUP
• 金额: $ 17.04万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-11 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6788858
• 关键词: antipsychotic agents; awareness; clinical research; decision making; human data; human subject; longitudinal human study; patient oriented research; schizophrenia; therapy compliance

DESCRIPTION (provided by applicant): This K23 Mentored Patient-Oriented Research Career Development Award will enable the candidate to develop the skills and experience necessary to become an independent investigator and scholar in interventions research for schizophrenia. The candidate is making a transition from health services to interventions research in order to address directly problems he has confronted as a clinician. The primary focus of work will be medication adherence. The overarching hypothesis is that medication non-adherence is a multifactorial barrier to good outcomes that is surmountable with specific interventions, or combinations of interventions, that address the underlying causes. An additional focus is on the decision-making capacity of persons with schizophrenia, which has important implications for medication adherence and for human subjects protections. The career objectives are to: 1) Improve understanding of the theory, concepts, and methodology related to design and analysis methods for clinical trials, 2) Gain additional exposure to issues and theoretical underpinnings of human subjects protections in vulnerable populations, with an emphasis on decision-making capacity, 3) Establish credibility as an investigator in the area of medication adherence and decision-making capacity, 4) Design and pilot test a novel clinical effectiveness trial addressing medication adherence and outcomes in a group of schizophrenic patients at high risk of non-adherence. Supervised research with experienced mentors is the main component of the career development plan. Coursework, tutorials, and workshops will be the mechanism to further develop methodologic skills and to develop expertise in treatment adherence and decision-making capacity. Two research projects will be pursued. Project 1 will use data collected in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial to conduct a novel longitudinal evaluation of medication adherence, awareness of illness, and decision-making capacity. Project 2 will establish the feasibility of a longitudinal effectiveness trial examining an intervention to improve medication adherence and outcomes in schizophrenia. This pilot study will build upon what is learned in Project 1 and will guide the design and provide preliminary data for a subsequent R01 application. At the end of the career development period, the applicant will have the skills and experience needed to lead studies of interventions designed to improve treatment adherence. The applicant's career will focus on designing and testing interventions to improve outcomes of persons who are severely affected by schizophrenia.

描述（由申请人提供）：该K23指导的面向患者的研究职业发展奖将使候选人能够发展精神分裂症干预研究的独立研究者和学者所必需的技能和经验。候选人正在从卫生服务到干预措施研究过渡，以解决他作为临床医生面临的直接问题。工作的主要重点是药物依从性。总体假设是，不遵守药物是对良好结果的多因素障碍，可以通过特定的干预措施或干预措施的组合来克服，以解决基本原因。另一个重点是精神分裂症患者的决策能力，这对药物依从性和人类受试者的保护具有重要意义。职业目标是：1）提高对与临床试验的设计和分析方法有关的理论，概念和方法的理解，2）获得较脆弱人群中人类受试者保护的问题和理论基础的额外暴露，并强调决策能力，3）在临床范围内建立了临床效率和决策效率的可信度，4）设计A A A Disaperion Aper piter APIREDING piter APIREDING piter A piter APIL，4）4）4）4）。一组具有不遵守风险的精神分裂症患者的依从性和结果。经验丰富的导师的监督研究是职业发展计划的主要组成部分。课程，教程和讲习班将是进一步发展方法论技巧并发展治疗依从性和决策能力的专业知识的机制。将追求两个研究项目。项目1将使用在干预效果（CATIE）精神分裂症试验的临床抗精神病药试验中收集的数据来进行对药物依从性，对疾病的认识和决策能力的新纵向评估。项目2将建立一项纵向有效性试验的可行性，该试验研究了一种干预措施，以改善精神分裂症的药物依从性和结果。这项试点研究将基于项目1中学到的知识，并将指导设计并为后续R01应用程序提供初步数据。在职业发展期结束时，申请人将具有领导旨在提高治疗依从性的干预措施的技能和经验。申请人的职业生涯将着重于设计和测试干预措施，以改善严重受精神分裂症影响的人的结果。