Allocation strategy for a controlled clinical trial to assess the Expert Patient Program Catalonia™ clinical effectiveness on diabetes

Abstract

Introduction: In Catalonia, self-care support is being developed through the Expert Patient Program Catalonia™ (EPPC™) integrated from primary health care which provides specific courses (taught by a patient, an equal) to improve patients' self-care skills. Whereas there is some evidence on acquiring self-care skills and improving perceived health between patients participating in this courses, its clinical effectiveness (on diabetes control, for example) remains unclear. To determine the clinical outcomes from attendance at a diabetes course under EPPC™ and to assess its effectiveness, a multicentre controlled clinical trial was designed and was implemented. The intervention arm consisted on following a course edition (once a week sessions during nine weeks) and the control arm was do not follow it. The assignment to both arms was in two steps: a randomization to take part in the trial followed by a masked assignment to one of both arms taking in consideration some patient preferences.