Objective: To describe the validation process of an educational material for diabetes self-management education among patients with type 2 Diabetes Mellitus (T2DM).
Methods: Methodological study, developed in three phases: construction of the educational material, validation of the educational material by judges, and by patients with T2DM (criterion validity). The validation process was conducted by 7 judges and 30 patients with T2DM. Criterion validity was assessed against gold standard by field expert. A 70% or more total disagreement of any of the items by the experts was decided to remove from the educational material. Criterion validity was measured by sensitivity, specificity, as well as the area under receiver operating characteristic (ROC) curve. The expected primary outcome was the HbA1c level to be decreased by 0.5% or more after the implementation of intervention guide among patients with T2DM.
Results: The changes suggested by judges were accepted and included in the final version of the educational material. All experts (100%) agreed that illustrations and texts in the education material motivate the patient with T2DM to understand the important of lifestyle modifications. The sensitivity of the developed intervention guide was 81.5% (95% CI=61.9-93.7%) with a specificity of 100.0% (95% CI=15.8-100.0%) and the area under ROC curve of 0.907. Intervention had a statistically significant reduction (p<0.05) in HbA1c [8.60% (IQR 2.60) vs. 7.40% (IQR 2.10)] and FBS level [159.00 mg/dl (IQR 77.50) vs. 134.00 mg/dl (IQR 40.50)] at the end of 3 months. Further, the mean BMI at baseline was higher compared to 3 months of intervention [24.88 Kg/m2 (SD ± 3.06) vs. 24.19 Kg/m2 (SD ± 2.79)] which was statistically significant (p=0.000).
Conclusion: The educational material was validated in terms of judgment and criterion validity. It would be used by nurse health educators for diabetes self-management education.