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

Area of Science:

• Clinical Trials
• Telehealth
• Chronic Disease Management

Background:

• Two randomized controlled trials (RCTs), Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD), targeted chronic disease management in patients with multiple comorbidities.
• Despite theoretical underpinnings and sound design, both trials resulted in null findings, indicating a need to re-evaluate trial design considerations.

Purpose of the Study:

• To discuss common design considerations across the CITIES and STOP-DKD trials.
• To provide implications for the design of future randomized controlled trials (RCTs) in chronic disease management.

Main Methods:

• Two parallel 1:1 randomized controlled trials (RCTs) with attention control groups.
• Recruitment of patients from diverse clinical practices in the Research Triangle area, North Carolina.

Main Results:

• Both the CITIES and STOP-DKD trials reported null findings, suggesting that the interventions did not achieve the desired clinical outcomes.
• The variation in patient populations and clinical settings between the two trials may have influenced the outcomes.

Conclusions:

• Future RCTs should pilot the enrollment process to ensure patient-intervention alignment with clinical outcomes.
• Analysis plans should be more targeted, incorporating heterogeneity of treatment effects.
• Early-stage RCTs should integrate implementation science principles to facilitate the transition of evidence into clinical practice.