Autonomous decision and behavior required in clinical trials: study with a socioeconomically vulnerable population

Abstract

Quasi-experimental study conducted to assess the effects of an educational intervention based on the Health Action Process Approach Model, in which autonomous decision-making and behaviors required for the participation in a clinical study were favored. This is an intervention study involving participants in a clinical trial conducted in the State of Minas Gerais, Brazil. The intervention was based on the social and cognitive variables of the Health Action Process Approach model and assessed by applying questionnaires before and after intervention. The results were compared using the McNemar test. The educational intervention favored knowledge on both the expectations about the results of the clinical trial and risk of infection by intestinal helminths, development of the ability to plan the behaviors required by the clinical trial and the necessary confidence to lead, keep, and retrieve them. Analysis of the results showed that the educational intervention favored both autonomous decision-making and the behavior required by clinical trials.