WCTD2016 Abstract Topics Design a Clinical Program for Success (17 abstracts)
1Clinical Science & Consulting, ERT, USA; 2Research, Endpoint Outcomes, USA.
Background: Patient engagement and adherence are critical to the success of clinical trials. Electronic patient-reported outcomes (ePROs) are increasingly used to evaluate diabetes clinical trial endpoints. This study characterized how subjects prefer to use various types of technology to report ePROs in a clinical trial. Considering patient preference during diabetes trial design may reduce patient burden and improve patient engagement.
Methods: 102 subjects with type 2 diabetes were surveyed regarding their preferences for using computers, smartphones, and internet in clinical trials.
Results: Subjects were diverse in age, sex, ethnicity, and technology use. 66% reported having a computer at home, 53% reported using the internet daily, and 48% reported owning a smartphone. Subjects reported that they would be willing to participate in a clinical trial using the internet for up to 1 month (19%), 26 months (25%), 12 years (17%), or 5+ years (18%). Similarly, subjects were willing to participate in a clinical trial using a smartphone for up to 1 month (19%), 26 months (29%), 12 years (11%), or 5+ years (18%). When asked what time of day they would prefer to complete a daily electronic diary, subjects preferred 8pm-midnight (32%), 8am-noon (19%) or noon-4pm (15%). Subjects thought it would be necessary (16%) or helpful (74%) to have an audible alarm to remind them to record their symptoms. In a multi-select question, subjects preferred to report their symptoms once a day for a clinical trial using a paper form (55%), an interactive voice system (51%), or a web-based form on the internet (49%).
Conclusions: Diabetes subjects are willing to use computers, smartphones, and internet in a clinical trial setting. Trial sponsors should consider patient preferences for specific technology features to reduce patient burden and improve engagement and adherence when using ePRO assessments.