NCT07045662

Health Literacy in Patients With Type 2 Diabetes Mellitus.

Effectiveness of Health Literacy in Patients With Type 2 Diabetes Mellitus on a Primary Health Care Protocol: a Randomized Pragmatic Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Ernanda Mezaroba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this pragmatic trial was to analyze the effectiveness of health literacy in patients with type 2 Diabetes mellitus (DM2) on a protocol of care in Primary Health Care (PHC) units. The secondary objective was to analyze the effectiveness of knowledge about diabetes, self-efficacy, and glycated hemoglobin (HbA1c) in DM2 patients on a PHC protocol, as compared to the regular care provided by the municipality. Patients from four Family Health Units (FHU) were part of the study, two units as control group (CG) - Usual Assessment, two as intervention group (IG) - Multidisciplinary Assessment, with 44 subjects in each group. The IG mirrors the care protocol, which includes individual visits with physician, nurse, and nutritionist, in addition to systematized collective activities. The CG received the usual care. The research raises the hypothesis that subjects in the IG had a better understanding of aspects related to the disease and were more active in their own health care, as compared to patients who did not receive the intervention.

Detailed description

This research was structured together with professionals who work in the management of the Municipal Health Department of the municipality under study due to the intention of implementing multidisciplinary care for people with Diabetes Mellitus, considering health literacy (HL) and national guidelines as the basis for structuring the assessment protocol. The research is also part of the Municipal Government Program, enhancing the knowledge translation and social impact. Therefore, it was decided to carry out a pragmatic trial, characterized by evaluating the effectiveness of interventions in a real scenario (Zuidgeest et al., 2017). The development of pragmatic trials contribute to the identification of scientific evidence that reduces gaps in primary health care, improving the Brazilian public health system.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
BEHAVIORAL	Multidisciplinary Assessment	The participants in the multidisciplinary assessment were followed by multidisciplinary teams from the study target-units, by individual and collective interviews, which mirror the care protocol. The frequency of individual visits was at least every six months by a nurse, a physician, and a nutritionist. Regarding the collective activities, the educational groups met for approximately 1 hour and 30 minutes on monthly basis over a period of six months. Considering that there were two FHU in the IG, each team held one activity per month. For the development of the collective activities, methods recognized for intensifying integration and participation, such as using simple language and confirming the participants' understanding of the information covered in the group were recommended.

Timeline

• Start date: 2024-07-12
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: Brazil