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Health Literacy in Patients With Type 2 Diabetes Mellitus.

NCT07045662 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

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.

Sponsors & Collaborators

  • Federal University of Rio Grande do Sul

    collaborator OTHER

  • Ernanda Mezaroba

    lead OTHER

Principal Investigators

  • Idiane Rosset, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045662 on ClinicalTrials.gov