From: Diabetes management intervention studies: lessons learned from two studies
Aspects to consider | Options to reduce limitations | Challenges |
---|---|---|
Engaging participants in the intervention group | Optimal engagement of involved HCPs: • Investigator meetings • Repeated training sessions of study sites • Peer-to-peer review | • Cost and time expensive • Consider optimal timing of training activities |
Support in device handling on individual levels: • Training for HCPs • Technical trainers should be familiar with study aims • Visualization of device-based intervention messages for subjects | • Cost and time expensive • Consider optimal timing of training activities | |
Detailed assessment of adherence: • Questionnaires (e.g., about therapy adaptations, perceptions of tools) • Result analysis of both: “per protocol population” and “intention to treat population” | • Adherence to some instructions are difficult to trace | |
Control group management | Cluster-randomization | • Limited statistical power • Calculated cluster numbers have to be feasible, ethically justifiable, and affordable |
Minimum attention to control group | • Disease management is complex • Standard of care cannot be fully standardized • Standard of care is often less defined and monitored than the interventional treatment | |
Pilot trials | • Cost and time expensive | |
Pretest periods | • Cost and time expensive | |
Third study arm | • Reduced statistical power ➔ requires more subjects ➔ cost and time expensive | |
Use of historical controls; retrospective data collection | • Identification of a suitable control data • Consider progress in treatment standards | |
Using two separate protocols for the two groups | • Informed consent forms should be well designed to avoid inclusion of interventional aspects | |
Two-stage randomization | • Ethical concern | |
Adaptive study designs | • Changes have to be planned and defined in advance • Implementation of adaptations has yet to be investigated |