Lessons learned from two randomized controlled trials: CITIES and STOP-DKD

Contemporary Clinical Trials Communications
Leah L ZulligHayden B Bosworth

Abstract

Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings. Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials. These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina. We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the inte...Continue Reading

Citations

Jun 3, 2021·International Journal of Molecular Sciences·Guido GembilloGianluca Trifirò
Aug 7, 2021·Journal of Personalized Medicine·Gopi BattineniFrancesco Amenta

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NCT01142908
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