家用iPad认知测试用于临床试验的可行性

IF 8.5 3区 医学 Q1 CLINICAL NEUROLOGY Jpad-Journal of Prevention of Alzheimers Disease Pub Date : 2016-03-01 DOI:10.14283/JPAD.2015.78
D. Rentz, M. Dekhtyar, J. Sherman, S. Burnham, D. Blacker, Sarah L. Aghjayan, K. Papp, R. Amariglio, A. Schembri, Tanya Chenhall, P. Maruff, P. Aisen, B. Hyman, R. Sperling
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Validation of these techniques is necessary to assess their utility in clinical trials.\n\n\nOBJECTIVES\nWe used a Computerized Cognitive Composite for Preclinical Alzheimer's Disease (C3-PAD) developed for iPad 1) to determine the feasibility of performing the C3-PAD at home by older individuals without the presence of a trained psychometrician; 2) to explore the reliability of in-clinic compared to at-home C3-PAD performance and 3) to examine the comparability of C3-PAD performance to standardized neuropsychological tests.\n\n\nDESIGN SETTING PARTICIPANTS\nForty-nine cognitively normal older individuals (mean age, 71.467.7 years; 20% non-Caucasian) were recruited from research centers at the Massachusetts General Hospital and Brigham and Women's Hospital. 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引用次数: 52

摘要

背景技术的进步使得在家中通过移动和触摸屏设备(如iPad或平板电脑)进行认知评估成为可能。这些技术的验证是必要的,以评估其在临床试验中的效用。目的:我们使用为ipad1开发的临床前阿尔茨海默病计算机化认知复合(C3-PAD)来确定老年人在没有训练有素的心理测量师在场的情况下在家进行C3-PAD的可行性;2)探讨临床与家庭C3-PAD表现的可靠性;3)检验C3-PAD表现与标准化神经心理测试的可比性。参与者49名认知正常的老年人(平均年龄71.467.7岁;20%非白种人)从马萨诸塞州总医院和布里格姆妇女医院的研究中心招募。参与者每隔一周进行两次门诊访问,并在家中进行5次30分钟的C3-PAD测试,以测量情景记忆、反应时间和工作记忆。MEASUREMENTSA信度分析探讨了6个备选C3-PAD测试版本的等效性。可行性评估计算了正确完成所有家庭测试的个人的百分比,而不是不完整的评估。相关分析检查了C3-PAD临床评估与C3-PAD家庭评估之间的关系,以及C3-PAD性能与标准化纸笔测试之间的关系。结果6个C3-PAD备选版本均具有良好的信度(Cronbach α系数=0.93)。49名参与者中有28人正确完成了所有的家庭课程,49人中有48人正确完成了五项中的四项。在完整和不完整的家庭评估中,参与者的年龄、性别或教育程度没有显著差异。单个临床C3-PAD评估和家庭C3-PAD评估彼此高度相关(r2=0.508, p<0.0001),表明家庭测试提供了可靠的临床评估数据。家庭C3-PAD评估与临床标准化纸笔测试之间也存在中度关联(r2= 0.168, p< 0.003)。结论家庭环境下C3-PAD评估可获得可靠、有效的认知数据。经过初步的临床培训,很大比例的老年人正确完成了家庭评估。家庭认知测试有望纳入临床试验设计。
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The Feasibility of At-Home iPad Cognitive Testing For Use in Clinical Trials.
BACKGROUND Technological advances now make it feasible to administer cognitive assessments at-home on mobile and touch-screen devices such as an iPad or tablet computer. Validation of these techniques is necessary to assess their utility in clinical trials. OBJECTIVES We used a Computerized Cognitive Composite for Preclinical Alzheimer's Disease (C3-PAD) developed for iPad 1) to determine the feasibility of performing the C3-PAD at home by older individuals without the presence of a trained psychometrician; 2) to explore the reliability of in-clinic compared to at-home C3-PAD performance and 3) to examine the comparability of C3-PAD performance to standardized neuropsychological tests. DESIGN SETTING PARTICIPANTS Forty-nine cognitively normal older individuals (mean age, 71.467.7 years; 20% non-Caucasian) were recruited from research centers at the Massachusetts General Hospital and Brigham and Women's Hospital. Participants made two in-clinic visits one-week apart and took five 30-minute alternate versions of the C3-PAD at-home measuring episodic memory, reaction time and working memory. MEASUREMENTS A reliability analysis explored equivalence of the six alternate C3-PAD test versions. A feasibility assessment calculated the percentage of individuals who completed all at-home tests correctly, in contrast to incomplete assessments. Correlational analyses examined the association between C3-PAD-clinic compared to C3-PAD-home assessments and between C3-PAD performance and standardized paper and pencil tests. RESULTS Excellent reliability was observed among the 6 C3-PAD alternate versions (Cronbach alpha coefficient=0.93). A total of 28 of 49 participants completed all at-home sessions correctly and 48 of 49 completed four out of five correctly. There were no significant differences in participant age, sex or education between complete and incomplete at-home assessments. A single in-clinic C3-PAD assessment and the at-home C3-PAD assessments were highly associated with each other (r2=0.508, p<0.0001), suggesting that at-home tests provide reliable data as in-clinic assessments. There was also a moderate association between the at-home C3-PAD assessments and the in-clinic standardized paper and pencil tests covering similar cognitive domains (r2= 0.168, p< 0.003). CONCLUSIONS Reliable and valid cognitive data can be obtained from the C3-PAD assessments in the home environment. With initial in-clinic training, a high percentage of older individuals completed at-home assessments correctly. At-home cognitive testing shows promise for inclusion into clinical trial designs.
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期刊介绍: The JPAD « Journal of Prevention of Alzheimer’Disease » will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including : neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes. JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.
期刊最新文献
Burden of Illness in People with Alzheimer's Disease: A Systematic Review of Epidemiology, Comorbidities and Mortality. Are Population-Level Approaches to Dementia Risk Reduction Under-Researched? A Rapid Review of the Dementia Prevention Literature. Expectancy Does Not Predict 18-month Treatment Outcomes with Cognitive Training in Mild Cognitive Impairment. Lifestyle and Socioeconomic Transition and Health Consequences of Alzheimer's Disease and Other Dementias in Global, from 1990 to 2019. Data-Driven Thresholding Statistically Biases ATN Profiling across Cohort Datasets.
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