Abstract

This study sought to evaluate the feasibility of a researcher configurable self-monitoring program. An initial prototype of the program was developed as a Windows-based drag and drop flow chart interface for the researcher to construct the self-monitoring or diary protocol to be scheduled and displayed to the subject on a Pocket PC. The usability of the desktop researcher interface was evaluated in a small sample of medication trial researchers whose ratings of the prototype were generally positive and provided directions for improvement. The subject interface was then evaluated in an “analog” drug trial of 49 smokers using nicotine gum. These subjects were randomly assigned to either paper-based log or Pocket PC self-monitoring for 3 weeks. Pocket PC subjects were significantly more compliant than the log subjects on recording in the second (65% vs. 39%) and third (69% vs. 39%) weeks of the trial but did not differ from the log condition on total recording entries, likely due to the restrictions on retrospective recording in the Pocket PC program. This study provides support for the feasibility of a researcher configurable electronic diary system which should substantially reduce the programming barriers to electronic self-monitoring and increase the use of real-time monitoring in clinical and research venues.

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