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Desirability and feasibility of wireless electronic monitoring of medications in clinical trials

  • Original Research
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Translational Behavioral Medicine

Abstract

Medication nonadherence is a vexing problem in health care necessitating patients and health professionals’ efforts to prevent, minimize, or reverse it. Research participants’ inconsistent medication taking obscures treatment efficacy and adds costs to biomedical research. Electronic monitoring devices (EMDs), like the Medication Event Monitoring System (MEMS), have grown in sophistication, providing precise, timely insights into individuals’ medication-taking patterns across clinical populations. This article reports on the desirability and feasibility study of using a wireless EMD in clinical research to promote adherence to clinical regimens and research protocols. Nonadherence in transplant patients has been linked to late acute rejection and graft loss. High levels of adherence (97.7 %) were documented for six renal transplant recipients for a mean of 6 months (M = 196.1 ± 71.2 days) who indicated acceptance of the technology. MEMS data confirmed the feasibility of using wireless EMDs to monitor medication use. Monitoring provides greater assurance that research studies reflect the biological impact of medications and provide a basis for targeting adherence enhancement efforts within research investigations.

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Acknowledgments

This work was supported by a grant from the National Institutes of Health (DK-13083). The authors thank all our subjects for their willingness to participate and also gratefully acknowledge the encouragement and support of Bernard Vrijens, Ph.D., Chief Science Officer at MWV Healthcare who provided the wireless caps and readers, as well as educational materials for their use.

Conflict of interest

All authors declare that they have no conflicts of interest.

Adherence to ethical principles

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for being included in the study.

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Authors and Affiliations

  1. Health Psychology, Department of Medicine, University of Minnesota Medical School, Mayo Mail Code 741, 420 Delaware Street, S.E., Minneapolis, MN, 55455, USA

    William N. Robiner & Thyra A. Fossum

  2. Department of Pediatrics, University of Minnesota Medical School, 420 Delaware Street, S.E., 13-152 Phillips-Wangensteen Building, Minneapolis, MN, 55455, USA

    William N. Robiner, Nancy Flaherty & Thomas E. Nevins

Authors
  1. William N. Robiner
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  2. Nancy Flaherty
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  3. Thyra A. Fossum
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  4. Thomas E. Nevins
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Corresponding author

Correspondence to William N. Robiner.

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Implications

Practice: New wireless medication monitoring technology can be employed to help patients track their own medication adherence and to allow researchers and health professionals to collaborate with them to optimize medication taking.

Policy: The inclusion of more precise and timely medication adherence information in clinical research has the potential to improve research and to provide greater assurance about the accuracy of the findings of clinical investigations.

Research: The use of wireless electronic medication monitoring devices is feasible to audit and may help improve medication adherence within clinical and translational research.

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Robiner, W.N., Flaherty, N., Fossum, T.A. et al. Desirability and feasibility of wireless electronic monitoring of medications in clinical trials. Behav. Med. Pract. Policy Res. 5, 285–293 (2015). https://doi.org/10.1007/s13142-015-0316-1

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