The overall goal of this project is to develop a computerized field evaluation system to monitor medication compliance and assess side effects and symptomatology during clinical drug trials (Medication Monitoring Field Assessment System, MMFES). The product will allow clinical drug trial researchers with no programming experience to set up customized field evaluation protocol to be delivered via palmtop computer to the subjects in the study. The program will use host management software (HMS) on a PC, palmtop performance software (PPS) on the palmtop, and the facility for easy uploads and downloads of protocols and data, both locally and remotely. The HMS will be used to develop field assessment protocols to assess self-monitored variables such as medication adherence, side effects, and changes in symptomatology between office visits. These assessment protocols will then be downloaded to and implemented on a palmtop (PDA) computer. The resulting palmtop program will allow for real-time monitoring on whatever schedule appropriate to the research goals. The program is designed with extensive branching capabilities to provide additional queries or instructions under specified conditions. Data collected on the palmtop can then be uploaded, either locally or remotely, to the HMS for subsequent analysis or importing to other databases or statistical programs. The Phase I project will emphasize development and testing of a prototype MMFES, but two small-scale evaluations will be implemented. One will involve a usability test of the program in a sample of drug evaluation professionals. The second will involve an initial trial of the MMFES in an """"""""analogue"""""""" drug trial with participants using nicotine gum.
This product could have broad applicability in a wide range of drug research and clinical settings where medications are being evaluated. Instead of using pencil-and-paper logs to track medication compliance, side effects, and symptomatology changes, drug researchers and medical professionals will be able to construct the field assessment protocol they desire on the PC and implement this protocol for study participants of patients on a palmtop computer.
