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P53: Patient Preferences for Clinical Trial Study Engagement

Poster Presenter

Jenny Ly

Senior Scientific Advisor
ERT
United States

Objectives

Patient engagement is crucial to collecting patient reported outcomes (PRO) data in clinical trials where primary/secondary endpoints support label claims. We initiated a patient survey to examine engagement strategies that would motivate patients to complete PRO assessments on a regular basis.

Method

Participants completed an online survey assessing their opinions on motivational strategies that would encourage them to complete PROs on a regular basis. Participants reported demographic information, including age, gender, and experience in clinical trials and using personal electronic devices.

Results

Patients from the US and UK were recruited via an online patient recruitment agency. A total of 325 participants completed the survey. Participants were diverse in age (M=52.5, SD=12.8, range=18 to 91 years) and 72% of the participants were female. 36% of participants reported that they had prior experience participating in clinical trials. A majority of participants (64%) indicated that they used their smartphone every hour while 31% said they used it a few times a day and <1% only once a day. Participants were less likely to use a tablet (8% reported every hour, 16% a few times a day, and 8% once a day). Participants reported using a desktop computer or laptop every hour (19%), a few times a day (25%), and once a day (6%). Almost half of the participants (48%) indicated that receiving compensation in the form of a small financial compensation, retail vouchers, or donation towards a charity of their choice would most motivate them to complete their PROs electronically on a regular basis in a clinical trial setting. 27% indicated that they would be most motivated if they received regular reports on the data they provided, received information that would help them manage their symptoms, or that their doctors or nurses would review the information with them. 21% reported that they would be most motivated by text message reminders, app notifications, email message reminders, and audible alarms and 5% preferred to have an easy-to-find list of contacts for support during the trial. Responses did not differ by gender (?6=4.88, p=0.56) or prior clinical trial participation (?3=2.68, p=0.44). Motivation strategy did differ by age (?9=28.38, p=0.001), with more participants in the 60-79 year old group preferring to receive information that would help them and their healthcare providers manage their symptoms compared to the other strategies.

Conclusion

PROs, in the form of daily questionnaires or diaries, are often used as primary/secondary endpoints to support labeling claims as well as other important commercial activities such as market access/pricing and publications. Understanding the importance of PRO data to product approval, market access, and use, we sought to examine engagement strategies that would motivate patients to complete PRO assessments on a regular basis. Failure of patients to consistently complete the PRO assessments can lead to missing data and threaten the internal validity and generalizability of the study results. Therefore, identifying appropriate patient engagement strategies to increase regular diary completion can influence the success of a clinical trial. Findings from our study showed that most participants endorsed financial compensation as the strategy that would most motivate them to complete PRO assessments. This was followed by the ability to receive regular reports in support of symptom management. The ability to receive reminders in the form of text messages, notifications, emails, and alarms was third as the most motivating strategy. However, preferences in motivational strategies were not consistent across age groups. Individuals 60-79 years of age identified the ability to receive regular reports that would help them and their healthcare providers manage their symptoms to be the most motivating in completing their PRO assessments. Our findings are consistent with other studies that showed motivation to participate in clinical trials depended on a number of demographic factors. Furthermore, the use of reminders and notification should be strategic to effectively target the needs of trial participants, which aligns with our experience and best practice. Lastly, while the issue of compensation in clinical trials still remains up for debate related to potential ethical concerns, this engagement factor continues to be reported as most influential in motivating compliance.