A large-scale RCT, the DANREHAB Trial, was designed to clarify whether the local model of CCR is superior to usual care for patients with CHF or IHD or patients with a high risk of IHD. Patients were centrally randomized to CCR or usual care, and a 12-month blinded primary outcome measure based on public registries was chosen.
the design and material of the trial has been described in a scientific paper where more detailes on the trial can be found. Link to abstract==>>
A detailed protocol for the statistical analysis has been planned in advance to ensure the ‘blindness’ of the analysis. The plan was apporved by signature by the Scientific Committe, the principal investigator and the study-independent statistician before conducting the primary analysis and breaking the randomisation code. The plan is available in English below.
Plan for statistical analyses