Open, Flexible Platform for CAM Adherence Monitoring and Mind-Body Investigations

用于 CAM 依从性监测和身心调查的开放、灵活平台

• 批准号: 7331659
• 负责人: K Jeffrey Eriksen
• 金额: $ 24.35万
• 依托单位: BIOELECTROMAGNETIC TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2007-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7331659
• 关键词: Open; Flexible; Platform; CAM; Adherence

DESCRIPTION (provided by applicant): There are very few proven biological markers to support complementary and alternative medicine (CAM) adherence investigations. Most tools currently available to CAM investigators are oriented to bio-feedback techniques and of little proven efficacy for use in quantitative research investigations. To support their work, CAM investigators need tools and technologies to assist in the identification of important bio-markers suitable for adherence monitoring, quantification, and analysis. Once the biomarkers have been identified, specific instrumentation and suitable algorithms and techniques can be developed to improve the accuracy of adherence measurement protocols. Our main goal in Phase I is to design, build and test a working prototype of a flexible, ambulatory CAM adherence monitor. In Phase II we will link this hardware platform with open software tools supporting CAM investigations. We will accomplish this goal by completing the following specific aims: Aim 1. Upgrade our preliminary instrument onto a new open architecture platform, addressing limitations of our preliminary device and targeting specific adherence measures. We will first survey the needs of CAM investigators nationally to identify a general purpose CAM investigative feature set. Then we will design to this set while addressing identified mechanical and electrical weaknesses of our preliminary system. Aim 2. Implement improved device firmware to simplify operation and support wireless PDA-based setup and control. Integration with a Personal Digital Assistant (PDA) will allow us to simplify setup, control, and monitoring operation as well as integrate PDA enabled subject input for monitoring adherence to any type of mind-body intervention. Aim 3. Implement improved device software components to simplify data file management efficiency and standardize the data file format. Given the variety of adherence measures that could be used in any particular study, the data file sizes can grow very large. We will address technical difficulties preliminary device operators experienced managing collected data files and also add support for standard biological data file formats such as EDF. Aim 4. Test the system on human subjects. We will assess subject comfort, ease of application by a novice technician, ease of use by the subject, validate physiological measures, and measure adherence to a meditation protocol for mind-body intervention. At the end of Phase I we will have demonstrated the feasibility of providing CAM investigators with open platform instrumentation modifiable to meet specific, potentially unique, investigative needs. If complementary and alternative medicine (CAM) is to benefit the population at large by being accepted into the mainstream of medical practice, it must be verified rigorously. Our product will offer the best toolbox for CAM research of mind-body interventions, as well as research in to the effects of pharmaceutical and CAM botanical agents, thus supporting quality CAM validation. To the extent that CAM is less expensive, has less side effects, and actually improves health, all of society will benefit.

描述（由申请人提供）：很少有已证实的生物标志物支持补充和替代医学（CAM）依从性调查。目前可供CAM研究人员使用的大多数工具都是面向生物反馈技术的，并且在定量研究调查中很少被证明有效。为了支持他们的工作，CAM研究人员需要工具和技术来协助识别适用于依从性监测、量化和分析的重要生物标志物。一旦确定了生物标志物，就可以开发特定的仪器和合适的算法和技术来提高粘附性测量方案的准确性。我们在第一阶段的主要目标是设计，构建和测试一个灵活的，动态CAM依从性监视器的工作原型。在第二阶段，我们将把这个硬件平台与支持CAM调查的开放软件工具联系起来。我们将通过实现以下具体目标来实现这一目标：