Implementation of a multicomponent process to obtain informed consent in the Diabetes Control and Complications Trial. The DCCT Research Group

Abstract

The Diabetes Control and Complications Trial (DCCT) is a multicenter, randomized clinical trial studying the effects of two different diabetes treatment regimens on the development and progression of early vascular complications in persons with insulin-dependent diabetes mellitus. A multicomponent program that utilized audiovisual and written material as well as behavioral practice was developed to educate prospective volunteers so that they could make an enlightened decision about participation in this complex and demanding long-term trial. The efficacy of this multicomponent approach was evaluated by administering a standardized test of knowledge about the trial and its requirements following the intensive educational process and again after 1 year's participation in the study. A mean score of 97% was achieved on the first test. The mean score of 91% 1 year after randomization indicated excellent retention of information. Moreover, the high degree of adherence during the first year of the trial suggests that the informed consent process provided the subjects with a realistic portrayal of the trial demands. The multicomponent informed consent process developed for the DCCT may serve as a model for other complex and demanding clinical trials where prospective subjects must be highly educated about the trial in order to participate effectively.