Digital Health Co-Design
Randomised Controlled Trial
Randomised Controlled Trial
In co-design studies, an RCT is used in the Deliver phase to rigorously test the effectiveness and acceptability of the final intervention, providing robust evidence to guide refinement and wider implementation.
Application Example
In a study developing a mobile clinical decision support system (CDSS) for health care providers managing chronic kidney disease in patients with diabetes, researchers applied a three-stage user-centered design framework. After exploratory interviews with diabetes specialist nurses and the development of a prototype tool, a pilot randomized controlled trial (RCT) was conducted to evaluate the app’s acceptability and impact.
The RCT involved 39 junior doctors randomly assigned to either the intervention group (using the CDSS app) or the control group (using paper-based guideline algorithms). Results showed no significant difference in diagnostic accuracy between groups overall, but doctors in the intervention group were more likely to achieve the minimum safety threshold in both case scenarios. Importantly, 83% of participants expressed satisfaction with the app, highlighting its ease of use, clear design, and time-saving potential. Negative feedback focused on navigation issues, technical bugs, and a need for additional clinical content (e.g., drug side effects, dose guidance, and patient medication history).
This case illustrates how RCTs in the Deliver phase serve as a rigorous evaluation method to test both the clinical impact and the acceptability of digital health tools in real-world conditions. By comparing outcomes between intervention and control groups, RCTs provide robust evidence of effectiveness, while user feedback collected alongside trial data offers actionable insights for refining the tool before wider implementation. (Alhodaib et al., 2020)