99% Study Retention and 90%+ eCOA Compliance in Real-world Diabetes Study Situation

Situation

A UK Innovative Medicines Initiative (IMI) study on the impacts of hypoglycemia (the HYPO METRICS study) required hundreds of eDiary Ecological Momentary Assessments (EMAs) — more than 300 over 10 weeks — as well as sensor-derived readings from continuous glucose monitors (CGMs) from 600 participants across nine European sites.

Risk

Compliance with a high-burden regime was a key risk to the bring-your-own-device (BYOD) study’s success; therefore, eCOA solution usability was paramount.

Diagnosis

uMotif worked with patients to optimize the eCOA application, including preferred tone of voice, questions asked, and the interfaces used for multiple daily assessments.

Actions

Data capture was fast, simple, and engaging for participants using the uMotif-patented eCOA solution interface. Study language and content reminded patients of their contribution to important research, encouraging continued participation.

Result

Fewer than 1% dropped out, and most participants completed all 304 questionnaires over 10 weeks, contributing more than 250,000 individual data points over the course of the study. This compares to 40% to 50% average dropout rates for real-world mHealth studies, according to industry analysis. Overall study data capture compliance exceeded 90%.

Lessons Learned

Clear, engaging, and enjoyable eCOA solution interfaces reduce the burden for participants and improve compliance, driving study success for sponsors. High-quality user interface design is best deployed in conjunction with direct involvement from the patients being supported. 

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