Medication Monitoring Field Evaluation System

DESCRIPTION (provided by applicant): The purpose of this Phase II project is to further develop and evaluate an electronic diary system, the Medication Monitoring Field Evaluation System (MMFES). Compared to pencil and paper diaries and logs, self-monitoring of medication use, side effects, symptomatology, and other variables via a handheld computer such as Palm or a PocketPC devices (PDAs) offers the potential for improved recording compliance as well as the potential to monitor in real time and to deliver complex monitoring protocols (e.g. conditional branching) in an easy to use PDA interface. Although electronic diaries have been used in some recent studies, a major barrier to regular use is the programming costs to produce the self-monitoring protocols on the PDA, costs which must be incurred with each new study. The MMFES provides researchers with a desktop program, which allows anyone without programming experience to create the self-monitoring protocols they wish to deliver and download these to the PDA for use by subjects, and then subsequently upload the data for analysis. In Phase I, a prototype MMFES was developed. A small group of researchers using the prototype provided positive ratings of the system and feedback for Phase II improvements. The program also was tested in an "analogue" drug trial with 49 smokers using nicotine gum and monitoring use, side effects, and symptoms either via paper and pencil log or via the MMFES on a PocketPC. The results of the feasibility trial showed that the MMFES produced greater recording compliance than the manual log entries and was rated as easy to use. In Phase II, the prototype will be fully developed, including Palm compatibility and remote web centric access. The Phase II program will first be tested in a pilot analogue drug trial similar to Phase I. One hundred researchers will evaluate the program following a demonstration and trial use of the desktop and PDA programs. Finally, the program will be evaluated in actual clinical drug trials to assess usability, concurrent validity, and recording compliance.