Health education and self-care in primary health care in patients with type 2 diabetes mellitus: protocol for a randomized clinical trial

Abstract

Abstract Objective: Testing a model of Health Education and self-care, based on the transtheoretical model of behavior change by Prochaska and DiClemente, on glycemic control, and important clinical and behavioral variables, against usual care, in patients with difficult-to-manage Type 2 Diabetes Mellitus. Methods: randomized, parallel, phase III clinical trial, with allocation ratio of 1:1, duration of 6 months, with primary endpoint HbA1c (%) between groups at the end of 6 months. The RCT will be conducted in the assigned territory of the patients, in order to reinforce the student-educator bond and the adherence of patients to the trial. Statistical Analysis Plan: descriptive analyses will be presented in continuous and categorical data, accompanied by the respective dispersion measures. Hypothesis tests will be performed for inferential analysis. For all conclusions related to primary and secondary endpoints, the intention-to-treat principle will be used as the primary analysis, accompanied by per-protocol analyses. Generalized linear models or mixed effects models will be used depending on the pattern of missing data found arising from intra-unit variability. Three interim safety reviews will be scheduled, performed by an independent panel, for potential early termination due in the case of harm, in accordance with the rules established by the study for patient safety. Stata 17.0.0 and R 4.3.1 statistical packages will be used for analysis, graphs, and figures. Test registration number: Brazilian Registry of Clinical Trials (RBR-5w2sqt); Pre-results.