MEDICATION ADHERENCE AND OUTCOMES IN SCHIZOPHRENIA

精神分裂症的药物依从性和结果

• 批准号: 6392923
• 负责人: Dawn Irene Velligan
• 金额: $ 30.5万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6392923
• 关键词: antipsychotic agents; behavior modification; behavioral /social science research tag; clinical research; cognitive behavior therapy; human subject; human therapy evaluation; mental disorder chemotherapy; outcomes research; psychopharmacology; schizophrenia; therapy compliance

DESCRIPTION (investigator's abstract): It is well established that poor adherence to antipsychotic medication can lead to relapse and re-hospitalization for schizophrenia patients. Prominent among the many reasons for non-adherence to pharmacotherapy are cognitive deficits, which contribute to forgetting to take medication and the failure to establish routines that would promote adherence. In a series of studies, we showed that Cognitive Adaptation Training (CAT) --- a manual-driven set of environmental supports (signs, checklists, electronic devices) designed to bypass specific neurocognitive deficits --- significantly improved symptomatology, adaptive functioning and rates of relapse in schizophrenia patients compared to control conditions. One interpretation of these results is that the environmental supports established specifically to increase adherence to medications were responsible for the better outcomes observed in CAT. We plan to examine this issue in a sample of 90 schizophrenia patients on atypical antipsychotic medications. After obtaining blood levels during hospital stay to determine intra-individual variability in plasma concentration of antipsychotic medication during optimal adherence, patients will be followed prospectively from the time of discharge for three months. This will allow us to examine predictors of poor adherence to atypical antipsychotics in the sample. Next, patients will be randomly assigned for 9 months to one of three treatment groups: (1) Full-CAT, (a comprehensive use of environmental supports to improve multiple areas of adaptive functioning), (2) Pharm-CAT (supports for medication adherence only), (3) Treatment as usual. All patients will be followed for 6 months after CAT treatments have been discontinued. Primary outcome variables will include medication compliance (blood levels), and measures of symptomatology, and adaptive functioning obtained at study entrance and each 3 months. Analyses of covariance, with pretreatment scores used as covariates, will be utilized to examine group differences on the outcome variables at the end of treatment and follow-up. We hypothesize that both Pharm-CAT and Full-CAT will improve adherence, symptomatology and rates of relapse but that only the comprehensive Full-CAT program will improve adaptive functioning. Moreover, we hypothesize that compliance and functioning will return to baseline levels six months after discontinuation of treatment.

描述（调查员的摘要）：已经很贫穷 遵守抗精神病药会导致复发和 精神分裂症患者的重新住院。在众多原因中突出 对于药物治疗的不遵守是认知缺陷，这有助于 忘记服药和未能建立常规 会促进依从性。在一系列研究中，我们证明了认知 适应训练（CAT）---一套手动驱动的环境支持 （标志，清单，电子设备）旨在绕过特定 神经认知缺陷---显着改善症状，适应性 与对照相比，精神分裂症患者的功能和复发率 状况。这些结果的一种解释是环境 专门为增加对药物依从性而建立的支持是 负责在CAT中观察到的更好的结果。我们计划检查一下 在非典型抗精神病药中的90名精神分裂症患者样本中的问题 药物。住院期间获得血液水平后确定 抗精神病药等血浆浓度的个体内变异性 在最佳依从性期间的药物治疗，将前瞻性遵循患者 从出院时间开始三个月。这将使我们能够检查 样品中对非典型抗精神病药的依从性不佳的预测因素。下一个， 患者将被随机分配9个月 组：（1）全猫（全面利用环境支持来改进 自适应功能的多个领域），（2）pharm-cat（药物的支持 仅依从性），（3）照常处理。所有患者将被遵循6 猫治疗几个月后已经停产。主要结果变量 将包括药物合规性（血液水平）和措施 症状学和自适应功能在研究入口和每个3 月份。协方差的分析，并用作协变量的预处理评分， 将利用在结果上检查群体差异 治疗结束和随访。我们假设Pharm-Cat和FullCat 将提高依从性，症状和复发率，但只有 全面的全猫计划将改善自适应功能。而且，我们 假设合规性和功能将返回基线级别六 停产后几个月。