CORE A: Participant Measures and Assessments

核心 A：参与者衡量和评估

基本信息

批准号：
10642914
负责人：
Robyn Lorraine Woods
金额：
$ 305.18万
依托单位：
HENNEPIN HEALTHCARE RESEARCH INSTITUTE
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：
2019-07-15 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10642914
关键词：
Activities of Daily Living Address Adherence Alzheimer&apos s Disease Aspirin Australia Biological Markers Biometry Blood Pressure Body Weight Body mass index Cardiovascular Physiology Clinical Cognitive Collection Colonoscopy Complement Complementary Medicine Country Data Data Analyses Data Collection Data Reporting Data Set Dementia Dose Elderly Ensure Evaluation Event Family Cancer History Fecal occult blood Funding Future Gait Health Health behavior Impaired cognition Incidence Kidney Diseases Laboratories Life Style Long-Term Effects Malignant Neoplasms Mammography Measures Mental Depression Methodology Modeling Molecular Analysis Moods Neurocognitive Neuropsychology Outcome PSA screening Participant Persons Pharmaceutical Preparations Physical Function Physical activity Physiological Procedures Quality of life Questionnaires Recording of previous events Renal function Research Resources Risk Risk Factors Screening for cancer Services Site Smoking Time Training Visit cancer diagnosis cognitive function cognitive performance comorbidity data cleaning data quality dietary disability exhaustion follow-up frailty genetic analysis genomic data grasp mild cognitive impairment participant retention phenotypic data psychosocial success

Activities of Daily Living Address Adherence Alzheimer&apos s Disease Aspirin Australia Biological Markers Biometry Blood Pressure Body Weight Body mass index Cardiovascular Physiology Clinical Cognitive Collection Colonoscopy Complement Complementary Medicine Country Data Data Analyses Data Collection Data Reporting Data Set Dementia Dose Elderly Ensure Evaluation Event Family Cancer History Fecal occult blood Funding Future Gait Health Health behavior Impaired cognition Incidence Kidney Diseases Laboratories Life Style Long-Term Effects Malignant Neoplasms Mammography Measures Mental Depression Methodology Modeling Molecular Analysis Moods Neurocognitive Neuropsychology Outcome PSA screening Participant Persons Pharmaceutical Preparations Physical Function Physical activity Physiological Procedures Quality of life Questionnaires Recording of previous events Renal function Research Resources Risk Risk Factors Screening for cancer Services Site Smoking Time Training Visit cancer diagnosis cognitive function cognitive performance comorbidity data cleaning data quality dietary disability exhaustion follow-up frailty genetic analysis genomic data grasp mild cognitive impairment participant retention phenotypic data psychosocial success

展开

项目摘要

CORE A. PARTICIPANT MEASURES AND ASSESSMENTS SUMMARY/ABSTRACT During the course of the ASPREE study, a vast amount of clinical, physical function, cognitive and quality of life data (~26 million data values) were collected from 19,114 participants by trained staff, resulting in excellent participant retention (82% with full involvement at the end of the study), compliance (74% overall) and data quality (99.6% accuracy). This Core will build on the operational success of ASPREE and provide methodological and operational support for all participant-related study activity by coordinating, directing and managing the physiological and neuropsychological assessments and questionnaires conducted routinely in ASPREE-XT participants in both the U.S. and Australia. The Core services will ensure quality, accuracy and thoroughness of data collection from participants through the implementation of comprehensive Standard Operating Procedures (SOPs) and to ensure adherence to SOPs, staff in both countries will be trained prior to commencement of study activity (see Admin Core). Data provided through the activities of Core A are the clinical nexus for all projects, as Core A will provide clinical endpoint triggers to Core B for follow-up. The longitudinal phenotypic data provided by Core A about ASPREE-XT participants will also be of vital importance for addressing the overall aims of this U19 through completion of Project analyzes. Specifically, the collection of information related to cancer screening, cancer incidence, progression, and outcomes are crucial for Project 1 (Cancer). Collection of cognitive data, depression and dementia endpoints are essential for assessing dementia and mild cognitive impairment outcomes in Project 2 (Dementia). Basic activities of daily living, physical function, exhaustion and physical activity data will be collected for assessment of disability and frailty for Project 3 (Disability). Consequently, the success of the U19 hinges upon the data that will be collected as part of this Core. 0

核心A.参与者措施和评估摘要/摘要在ASPREE研究的过程中，大量的临床，身体机能，认知和生活质量训练有素的员工从19,114名参与者中收集了数据（约2600万个数据值），从而获得了出色的数据参与者保留（研究结束时有82％的参与），合规性（总体74％）和数据质量（精度为99.6％）。该核心将基于Aspree的运营成功并提供方法论以及通过协调，指导和管理所有与参与者相关的研究活动的运营支持生理和神经心理学评估和问卷调查在Aspree-XT中进行定期进行美国和澳大利亚的参与者。核心服务将确保质量，准确性和彻底性通过实施综合标准操作程序从参与者那里收集数据（SOP）并确保遵守SOP，两国的员工将在开始学习之前接受培训活动（请参阅管理员核心）。通过核心A活动提供的数据是所有项目的临床联系，作为核心A将为B核B提供临床终点触发器进行随访。提供的纵向表型数据核心A关于Aspree-XT的参与者对于解决总体目标也至关重要 U19通过完成项目分析。具体而言，与癌症有关的信息收集筛查，癌症的发病率，进展和结果对于项目1（癌症）至关重要。收集认知数据，抑郁症和痴呆端点对于评估痴呆和轻度认知至关重要项目2（痴呆症）中的损害结果。日常生活，身体机能，疲惫和将收集体育活动数据，以评估项目3（残疾）的残疾和脆弱性。因此，U19的成功取决于将作为该核心的一部分收集的数据。 0