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[Preprint]. 2025 Nov 18:rs.3.rs-7660915.
doi: 10.21203/rs.3.rs-7660915/v1.

Implementation Framework to Increase Patient Adherence in Clinical Trials Utilizing Wearable Devices

Meghan McCarthy  1 , Aubrey Pope  1 , Gabriel Smock  1 , Joshua Kim  1 , Bryan Rettner  1 , Alexander Zhu  1 , Danny Wang  1 , Anna Hamer  1 , Quiana Guo  1 , Allan-Jacob Castillo  1 , Alexandra Potter  1 , Yuhang Zhang  2   3 , Lizi Zhang  2   3 , Zhengyu Fang  4 , Xiao Li  2   3   4   5   6 , Chi-Fu Jeffrey Yang  1
Affiliations

Implementation Framework to Increase Patient Adherence in Clinical Trials Utilizing Wearable Devices

Meghan McCarthy et al. Res Sq. .

Abstract

Background: Wearable devices are increasingly integrated into clinical trials to collect continuous physiologic data in inpatient, outpatient, and home settings. Consistent patient adherence is essential to ensure high-quality, analyzable data, yet challenges such as digital literacy, device syncing, and socioeconomic disparities persist. Lessons learned from an R01-funded trial at Massachusetts General Hospital, which incorporated wearable devices to extend a machine learning algorithm for monitoring postoperative events after cardiothoracic surgery, offer insight into strategies to improve adherence.

Methods: Insights from the design and implementation of the NIH-NHLBI-funded Wearables Clinical Trial at Massachusetts General Hospital and Case Western Reserve University were synthesized with findings from a focused literature review. This process was used to develop a practical framework of strategies to optimize adherence in clinical trials using wearable devices.

Results: Key strategies include defining clear inclusion and exclusion criteria, offering both virtual and in-person recruitment, reinforcing digital literacy early and repeatedly, establishing regular data monitoring checkpoints, and maintaining targeted participant contact to support accountability. These approaches may enhance participant engagement, reduce data missingness, and promote equitable participation.

Conclusions: Strategies that address technological barriers, participant engagement, and data monitoring can enhance adherence in clinical trials using wearable devices. The proposed framework provides guidance for optimizing study design, improving data quality, and expanding trial accessibility across diverse patient populations. Lessons learned from wearable device integration can inform future studies and facilitate broader adoption of digital health technologies in clinical research.

Trial registration: Not applicable: this article does not report trial results.

Keywords: adherence; clinical trials; digital health; digital literacy; implementation strategies; remote monitoring; wearable devices.

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Conflict of interest statement

Competing interests The authors declare that they have no competing interests.

Figures

Figure 1:
Figure 1:. Workflow of WCT-MGH participation
Participation checkpoints in the WCT-MGH
See this image and copyright information in PMC

References

    1. Kassaw M, Amare G, Shitu K, Tilahun B, Assaye BT. Willingness to use remote patient monitoring among cardiovascular patients in a resource-limited setting: a cross-sectional study. Front Digit Health. 2024. Sept 17;6:1437134. - PMC - PubMed
    1. Rising CJ, Gaysynsky A, Blake KD, Jensen RE, Oh A. Willingness to Share Data From Wearable Health and Activity Trackers: Analysis of the 2019 Health Information National Trends Survey Data. JMIR Mhealth Uhealth. 2021. Dec 13;9(12):e29190. - PMC - PubMed
    1. Guo C. Why Wearable DHTs Are Bringing More Meaningful Data Collection to Patient-Centric Clinical Trials. Applied Clinical Trials Online. https://www.appliedclinicaltrialsonline.com/view/why-wearable-dhts-are-b.... Accessed 3 May 2025.
    1. U.S. Food and Drug Administration. What is Digital Health? FDA Digital Health Center of Excellence. https://www.fda.gov/medical-devices/digital-health-center-excellence/wha.... Accessed 20 July 2025.
    1. Fedor S, Lewis R, Pedrelli P, Mischoulon D, Curtiss J, Picard RW. Wearable Technology in Clinical Practice for Depressive Disorder. Friend SH, Ginsburg GS, Picard RW, Drazen JM, editors. N Engl J Med. 2023. Dec 28;389(26):2457–66. - PubMed

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