Healthc Inform Res.  2017 Oct;23(4):249-254. 10.4258/hir.2017.23.4.249.

Development and Application of Direct Data Capture for Monitoring Medication Compliance in Clinical Trials

• Kim EY

• KMID: 2396415
• DOI: http://doi.org/10.4258/hir.2017.23.4.249

Abstract

OBJECTIVES
The monitoring of medication compliance in clinical trials is important but labor intensive. To check medication compliance in clinical trials, a system was developed, and its technical feasibility evaluated.
METHODS
The system consisted of three parts: a management part (clinical trial center database and a developed program), clinical trial investigator part (monitoring), and clinical trial participant part (personal digital assistant [PDA] with a barcode scanner). The system was tested with 20 participants for 2 weeks, and compliance was evaluated.
RESULTS
This study developed a medication compliance monitoring system that used a PDA with a barcode scanner, which sent reminder/warning messages, logged medication barcode data, and provided compliance information to investigators. Registered participants received short message service (SMS) reminder/warning messages on their PDA and sent barcode data at the dosing time. The age range of the participants was 29 to 73 years. Five participants were <50 years old and 8 were ≥65 years old. The total mean compliance rate was 82.3%. The mean compliance rate was 83.1% in participants <65 years old and 81.1% in those ≥65 years old.
CONCLUSIONS
The system was feasible, usable, and effective, even with elderly participants, for monitoring medication compliance in clinical trials using a PDA with a barcode scanner, and may improve the quality of clinical trials.

Keyword

Direct Data Collection; Medication Adherence; Clinical Trial; Handheld Computer; Aged Humans

MeSH Terms

Aged
Compliance
Computers, Handheld
Humans
Medication Adherence*
Research Personnel
Text Messaging

Figure

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  Figure 1 The PDA-based clinical trial drug compliance monitoring system. The system consists of a management part (clinical trial center database [CTC DB] and software), clinical trial investigator part (monitoring), and clinical trial participant part (PDA).

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  Figure 2 The drug compliance management and monitoring system. Participant data are stored (upper right panel) and displayed as a summary and bar chart (left upper and lower panels). A reminder or warning message could be sent to participants (right lower panel).

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