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.
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