Reimagining Health Literacy in the Digital Era

Written by:
Pamela Tenaerts, MD, MBA, Chief Medical Officer at Medable

Fully 36% of Americans have limited health literacy skills, and among indigent and minority patients in urban areas, this number rises to over 80%.¹ That is not just surprising, but unsettling.

Health literacy is a foundational concept in modern clinical research. Each October during Health Literacy Month, the clinical research industry has an important opportunity to refocus on how to make trial participant comprehension integral to meaningful health outcomes, sustained engagement, and fair representation in clinical trials.²

Health literacy initiatives have historically focused on enabling all people, regardless of access, background, ability, or experience, to understand and act on health information in ways that improve well-being. The same concept is paramount to sustainable improvements in clinical research.

But health literacy in the modern age also requires digital literacy, especially with the increasing adoption of digital tools in clinical trials. Trial participants must now be able to access and interpret information not only in written consent forms, but also in digital formats, including applications (apps), remote data capture platforms, wearable devices, and telehealth formats for remote clinical trial settings. Essentially, “health literacy” now extends to technical ability, data sharing, device usage, and virtual engagement, making digital literacy an inseparable partner of health literacy. Studies even suggest that individuals with higher *digital health* literacy have better self-management and participation in their own medical decisions, mental and psychological states, and overall quality of life.³

In this new paradigm, trial participation hinges on whether technologies, such as eCOAs, eConsent, Telemedicine, and wearables, are easily accessible. Further, it requires access to minimum technology requirements (i.e., a smartphone, Wi-Fi, or 4G internet speeds) and comes with a cost, which should not be borne by the participants. Most importantly, it requires clear communication between trial teams and participants, plus training for both on how to use these technologies in clinical trials.

A recent pilot study led by Corneli and colleagues at Duke University examined participant comprehension and satisfaction using 1) text-only eConsent and 2) multimedia-enhanced eConsent approaches. The results showed that leveraging interactive elements such as videos, e-calendars, and real-time comprehension checks significantly improved understanding and confidence in the participants’ study decisions.⁴ Access to this technology, combined with digital literacy, not only improved the participants’ trial experience but also, in turn, may help to improve representation in clinical trials.

Historically, some patients have been skeptical about trial participation due to geographic barriers such as extensive travel, but also a lack of trial understanding. According to a recent survey, patients balk at trials due to the complexity of participating.⁵ “Patient groups and communities are asking us to simplify the language for all patient interactions beginning with the patient information leaflet and informed consent form,” said Xoli Belgrave, executive director of drug development services at Parexel. “When patients are overwhelmed, they can either pull away or sign without being informed.”

As technologies become more accessible, even for those with limited digital literacy, and as participants grow more informed through user-centered digital solutions, trial participation can expand to reach a broader and more diverse population.

Systematic reviews reinforce that building participant-facing tools with multimedia content and plain language increases participant recall, satisfaction, and trust within research settings.⁶ The best eConsent models foster an ongoing and technology-assisted interactive conversation between participants and study personnel, rather than a one-time transaction. Guidance from both the FDA and EMA sets a clear expectation for usability and comprehension, making them necessary standards for trial quality, data integrity, and broad-reaching participant representation.^7,8 These operational standards require moving beyond compliance, elevating digital literacy and access as persistent priorities in trial design and execution.

As decentralized and hybrid trials become standard, representation increasingly depends on participants’ digital literacy. Limited technology skills can present obstacles to onboarding, increase dropouts, and diminish confidence and trust in trial conduct.⁹ Sponsors and CROs that enable technology access and support increased digital literacy help ensure the broadest participation. Technology-centered participant tools can also be enhanced with special capabilities that reflect the needs of people with varied backgrounds and differing levels of digital literacy to further drive participation.

The future of clinical research is increasingly digital, and it offers potential for broad engagement, flexible participation, and more representative trial outcomes. To realize these opportunities, organizations must design every aspect of study participation, from technology choices to communication materials, to support representation and actionable comprehension.

Health literacy and digital literacy together are now required operational standards. Every stakeholder, from investigators to technology developers to regulators, plays a role in ensuring research is accessible, trusted, and representative of all people. The path to progress runs through comprehension, usability, and careful attention to the participant’s experience.

References

1. Bickmore T, Pfeifer LM, Jack BW. Taking the virtual nurse into the hospital: deployment and integration into hospital workflows. Int J Med Inform. 2009;78(6):437-445. https://www.bu.edu/fammed/projectred/publications/BickmoreVirtualNurse.pdf
2. Office of Disease Prevention and Health Promotion. October is health literacy month! Accessed October 23, 2025. https://odphp.health.gov/news/202010/october-health-literacy-month
3. World Health Organization. Health Literacy Development for the Digital Era: A Global Perspective. Geneva, Switzerland: World Health Organization; 2023.
4. Corneli A, Starling S, Choi Y, Vosylius J, Madre L, Mackinnon A, Tenaerts P. Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study. Pilot Feasibility Stud. 2024;10:110. doi:10.1186/s40814-023-01432-w
5. Parexel. Americans cite barriers to clinical trial participation, new survey finds. PharmaVoice. 2024. https://www.pharmavoice.com/news/americans-clinical-trials-barriers-parexel-survey/741438/
6. Williams H, Patel R, Villanueva L, et al. Measuring comprehension and retention of informed consent among clinical trial participants: a systematic review. Contemp Clin Trials. 2022;115:106717. doi:10.1016/j.cct.2022.106717
7. U.S. Food and Drug Administration. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance for Industry, Investigators, and Other Stakeholders. Silver Spring, MD: FDA; 2023.
8. European Medicines Agency. Guideline on Computerised Systems and Electronic Data in Clinical Trials. EMA/228236/2023. Amsterdam, the Netherlands: EMA; 2023.
9. Anderson M, Johansson M, Patel V, et al. Digital literacy as a predictor of retention in decentralized trials. NPJ Digit Med. 2023;6(1):112. doi:10.1038/s41746-023-00871-5