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ePRO for Older Participants: What the Evidence Actually Shows

Signant Health
Jun 22, 2026
eBook
Participant dropout strategies in anti-obesity medication clinical trials

ePRO adherence in older clinical trial participants reaches 88%, higher than in general adult populations, from an analysis of 196 clinical trials. Signant Health's qualitative research, published in the Journal of Comparative Effectiveness Research (2020), found the primary barrier is performance anxiety, not physical capability, and that it is addressable through training and ePRO design decisions made before the study starts. 

Key Points: Inside, you'll find  

  1. Evidence from an analysis of 196 clinical trials showing that older participants achieve 88.0% ePRO adherence. This ranks second only to infant caregivers (93.2%), outperforming adults (83.4%), teenagers (79.5%), and pediatric populations (71.1%).
  2. Findings from Signant Health's qualitative research with older participants in the UK, covering attitudes toward mobile technology, learning preferences, and responses to remote appointments, with direct participant quotations across age groups from 65 to 83.
  3. Why the assumption that older participants cannot manage ePRO technology is not supported by the data, and why 90% of participants in the study had prior experience using an electronic medical device at their doctor's request.
  4. Five evidence-based best practices for ePRO implementation with older populations: segment by age subgroup (55–74, 75–84, 85 and over), prioritize hands-on training, consider tablets and BYOD for familiarity and larger screen size, employ reminders and alarms, and provide in-solution support features.
  5. How ePRO design choices, including PIN code entry, clear font size, and straightforward navigation, can address the technology concerns that older participants raise without requiring a fundamentally different solution architecture.
  6. The full eBook contains the complete research methodology, age-segmented adherence data from 196 trials covering 104,663 screened participants, the qualitative findings by theme, and the five-practice implementation framework with design recommendations for each. 
Why Age-Based Exclusion from ePRO Studies Is a Regulatory and Data Quality Risk Now   
 
For an older person managing a chronic condition across months of clinic visits, the assumption that they cannot use a tablet or smartphone is not a neutral operational decision. It is a decision that removes them from access to studies that could benefit them, limits the representativeness of the trial population, and reduces the generalizability of the evidence generated. Poor representation of older participants in clinical trials leads to inadequate evidence for drug therapy in older populations, a concern cited by both the EMA and the FDA. 

The EMA's 2017 guideline on the investigation of medicinal products in the elderly, and the FDA's 2022 draft guidance on diversity action plans for clinical studies, both signal that regulators expect sponsors to document why older participants are or are not included and to demonstrate that technology choices do not constitute an unintended exclusion barrier. That expectation is active now, for trials in design today. An analysis of 196 clinical trials confirms that older participants aged 55 and overachieve an 88.0% ePRO adherence rate when using smartphone or tablet devices, a figure that ranks second only to infant caregivers across all age groups studied. The assumption that older participants will not use ePRO technology is not borne out by the evidence. It is, however, shaping design decisions that exclude this population from studies where their participation matters.  
 
What the Research Shows and What Sponsors Should Design Differently
 
Sponsors designing ePRO studies with older participant populations have often defaulted to provisioned devices on the assumption that older participants cannot manage unfamiliar technology. The Signant Health research, conducted by Katie Garner and Bill Byrom PhD and published in the Journal of Comparative Effectiveness Research (2020), found that this framing misidentifies the barrier. The primary challenge is not physical capability with technology. It is performance anxiety: the concern that they will make an error, look uninformed, or fail to operate the device correctly in front of site staff or at home unsupervised. 

This distinction matters for ePRO design because performance anxiety is addressable through specific, practical interventions that do not require a different platform or a fundamentally different solution. Seventy percent of participants in the study were already familiar with tablets. All expressed a desire to learn and a personal interest in doing so. 

Sixty percent preferred video training with written supplementary materials, and most preferred learning by doing with guided hands-on practice. Ninety percent had prior experience using an electronic medical device at the request of their doctor, and all expressed at least reluctant acceptance of using a new device if their doctor asked them to. The full eBook provides the age-segmented adherence data from 196 trials, the qualitative findings across themes including simplicity and familiarity, learning preferences, authority, and remote appointments, and the five-practice implementation framework with specific design recommendations for each.  
 
 

"Older participants do not require a dramatically different ePRO solution. The population does need a clear, easy-to-read screen, a straightforward interface, and training that builds confidence through hands-on practice. The evidence shows they are among the most adherent groups in clinical trials when these conditions are met." - Katie Garner, Therapeutic Area Advisor, Signant Health UK; co-author, Journal of Comparative Effectiveness Research (2020) 

Do older clinical trial participants achieve lower ePRO adherence than younger populations?

No. An analysis of 196 clinical trials using smartphones or tablets found that older participants achieved an 88.0% ePRO adherence rate, higher than the 83.4% recorded for general adult populations, 79.5% for teenage populations, and 71.1% for pediatric populations. Older participants ranked second only to infant caregivers at 93.2%. Adherence to scheduled data collection is a reliable proxy for technology acceptability in this population.

What is the biggest challenge when deploying ePRO with older clinical trial participants?

The primary challenge is performance anxiety: the concern that older participants will make errors or fail to operate the device correctly, particularly when unsupervised at home. Physical challenges such as deteriorating eyesight are secondary concerns. Research by Garner and Byrom (Journal of Comparative Effectiveness Research, 2020) found that all study participants accepted and used the ePRO tools, with anxiety directly mitigated by hands-on training, device familiarity, and in-solution support features.

Should sponsors use provisioned devices or BYOD for older ePRO participants?

Both are appropriate, and the choice should be informed by participant familiarity. Seventy percent of older participants in the Signant Health study were already familiar with tablets, making larger-screen provisioned tablets or BYOD a practical option that may reduce performance anxiety. Where participants do not own a suitable device, provisioned devices remain the fallback. Sponsors should segment older participants by age subgroup (55–74, 75–84, 85 and over) when making modality decisions, as technology familiarity and physical capability vary across these subgroups.

How should ePRO training be designed for older clinical trial participants?

Training for older participants should prioritize hands-on practice over information transfer, as most participants in the Signant Health research preferred learning by doing. Sixty percent preferred video training with supplementary written materials, while 10% preferred audio. Training should be available as a reference at all times, not only at the onboarding visit. Sponsors can further mitigate performance anxiety by keeping the ePRO interface to a simple four-step flow: enter PIN, answer the question, advance, and submit.

 
 

AUTHOR BIO 

Name: Katie Garner &  Bill Byrom
Title and Credentials: Katie Garner, Therapeutic Area Advisor, Signant Health UK |  Bill Byrom, PhD Principal, eCOA Science, Signant Health
Bio: Katie Garner specializes in ePRO implementation and participant-centered data collection strategy across global clinical studies. Her published research on older participant attitudes toward ePRO and mobile application use in clinical trials, conducted with Bill Byrom, PhD, and published in the Journal of Comparative Effectiveness Research (2020), provides the primary evidence base for this eBook. 

Bill Byrom has worked in the pharmaceutical industry for more than 30 years and has authored over 70 publications and two industry textbooks on electronic patient-reported outcomes. His research spans ePRO measurement equivalence, BYOD implementation, and participant-centered data collection across diverse clinical trial populations, including older participants and oncology cohorts. 

 

Designing an ePRO strategy for a study with older participants and need evidence-based guidance on device selection, training design, and adherence optimization? Speak to a Signant eCOA expert. 

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