Cognitive Intervention to Improve Memory in Heart Failure Patients

认知干预可改善心力衰竭患者的记忆力

• 批准号: 9174226
• 负责人: BRUNO GIORDANI
• 金额: $ 54.54万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9174226
• 关键词: Address; Adopted; Affect; Alleles; American; Apolipoproteins; Attenuated; Biological Markers; Brain; Brain-Derived Neurotrophic Factor; Cardiovascular system; Chronic Disease; Cognition; Cognitive; Computers; Congestive Heart Failure; Control Groups; Data; Data Collection; Delayed Memory; Educational Intervention; Event; Evidence based treatment; Gender; Genetic Polymorphism; Genotype; Health; Health Care Costs; Health education; Health system; Healthcare; Heart failure; High Prevalence; Hippocampus (Brain); Hour; Impaired cognition; Individual; Injury; Insurance Carriers; Intervention; Intervention Studies; Knowledge; Memory; Memory Loss; Modeling; Negative Finding; Neuronal Plasticity; Outcome; Patient-Focused Outcomes; Patients; Performance; Personal Satisfaction; Principal Investigator; Publications; Quality of life; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Recruitment Activity; Research; Sample Size; Sampling; Serum; Short-Term Memory; Speed; Testing; Time; Training; Training Programs; United States National Institutes of Health; Work; abstracting; active control; arm; base; biobehavior; cerebral hypoperfusion; clinical practice; cognitive function; cognitive process; cognitive training; computerized; cost effective; cost effectiveness; cost utility analysis; depressive symptoms; design; disabling symptom; efficacy testing; evidence base; fitness; health related quality of life; improved; information processing; instrumental activity of daily living; intervention effect; male; memory recall; mortality; neurotrophic factor; novel therapeutic intervention; primary outcome; programs; response; secondary outcome; statistics; symptom management; therapy design; treatment as usual; trend; willingness to pay

Abstract This application is in response to NIH FOA PA-15-017 investigating interventions to attenuate cognitive decline in individuals with cognitive impairment. It is consistent with the NINR priority of improving management of symptoms of chronic illness to improve quality of life. From 23% to 50% of the 5.1 million Americans with chronic heart failure (HF) have comorbid cognitive dysfunction including the debilitating problem of memory loss. We found that memory loss in HF was an independent predictor of 12-month all- cause mortality (n=166). We tested the computerized cognitive training intervention using BrainHQ in two small studies (n=40; n=27) and found that compared with HF patients who completed the active control health education intervention, HF patients who completed BrainHQ had significantly improved memory (delayed recall) (effect size [ES]=0.75), serum brain-derived neurotrophic factor (BDNF) levels (ES=1.21), and working memory (ES=0.64). We propose a three-arm randomized controlled trial of 264 HF patients within four equal sized blocks on baseline cognitive function (normal/low) and gender. Specific aims are to: 1) evaluate the efficacy of computerized cognitive training intervention using BrainHQ to improve memory and serum BDNF levels (primary outcomes), working memory, instrumental activities of daily living, and health-related quality of life among HF patients; 2) evaluate the incremental cost-effectiveness of BrainHQ among HF patients; and 3) examine depressive symptoms, BDNF genotype of the Val66Met polymorphism, and apolipoprotein-ε4 allele as moderators of BrainHQ effect on primary and secondary outcomes. A sample of 264 HF patients will be randomly assigned to: 1) BrainHQ; 2) active control computer-based general cognitive stimulation intervention using crossword puzzles; and 3) usual care control with no specific computerized cognitive intervention. BrainHQ is an easily disseminated, scientifically based intervention designed to improve memory by increasing speed and accuracy of information processing. It is an 8 week, 40-hour program that is individualized to each patient's performance. The active control intervention (computer-based crossword puzzles) will serve as a comparison for computer use and performance of a cognitive activity that may provide general stimulation. The usual care control group will serve as a comparison with patients who are not receiving computer-based cognitive interventions. Data collection will be completed at baseline and at 10 weeks, 4 months and 8 months after baseline. Descriptive statistics, mixed model analyses, and cost-utility analysis using intent-to-treat approach will be computed. This research will provide new knowledge about efficacy of BrainHQ to improve memory and increase serum BDNF levels in HF. If efficacious, the intervention will provide a new therapeutic approach that is easy to disseminate to treat a serious comorbid condition of HF. If cost-effective, insurers will be more likely to provide coverage for the intervention and therefore health systems will be more likely to offer it as a treatment option.

摘要 本申请是对NIH FOA PA-15-017调查干预以减弱认知功能的回应。 认知障碍患者的认知能力下降。这与NINR的优先事项是一致的， 管理慢性病的症状，以改善生活质量。从510万人的23%增加到50% 患有慢性心力衰竭（HF）的美国人患有共病的认知功能障碍，包括 记忆丧失的问题。我们发现HF患者的记忆丧失是12个月所有- 死亡原因（n=166）。我们使用BrainHQ在两个实验中测试了计算机化认知训练干预 小型研究（n=40; n=27）发现，与完成积极控制健康的HF患者相比， 通过教育干预，完成BrainHQ的HF患者的记忆力显著改善（延迟）， 回忆）（效应量[ES]=0.75），血清脑源性神经营养因子（BDNF）水平（ES=1.21），和工作 内存（ES=0.64）。我们提出了一个三臂随机对照试验，264例HF患者在四个相等的 基线认知功能（正常/低）和性别的大小块。具体目标是：（1）评估 BrainHQ电脑认知训练干预改善记忆和血清BDNF的效果 水平（主要结果），工作记忆，日常生活的工具性活动，和健康相关的质量 2）评估BrainHQ在HF患者中的增量成本效益;以及3） 检查抑郁症状、BDNF基因型Val 66 Met多态性和载脂蛋白-ε4等位基因 作为BrainHQ对主要和次要结局影响的调节者。将对264例HF患者进行样本分析， 随机分配到：1）BrainHQ; 2）基于计算机的一般认知刺激干预的主动控制 使用填字游戏;和3）没有特定的计算机认知干预的常规护理控制。 BrainHQ是一种易于传播的，基于科学的干预措施，旨在通过以下方式改善记忆力： 提高信息处理的速度和准确性。这是一个为期8周，40小时的计划， 根据每个病人的表现进行个性化治疗。主动控制干预（基于计算机的填字游戏 谜题）将作为计算机使用和认知活动表现的比较， 一般刺激。常规护理对照组将作为与不进行常规护理的患者的比较。 接受基于计算机的认知干预。将在基线和10时完成数据收集 基线后3周、4个月和8个月。描述性统计、混合模型分析和成本效用 将计算使用意向治疗方法的分析。这项研究将提供新的知识 BrainHQ改善HF患者记忆和提高血清BDNF水平的功效。如果有效， 将提供一种易于传播的新治疗方法来治疗严重的共病， HF。如果具有成本效益，保险公司将更有可能为干预措施提供保险，从而为健康提供保险 系统将更有可能将其作为一种治疗选择。