NCT07045662Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 24 Apr 2025
- Start date
- Jul 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Ernanda Mezaroba
- Diseases
- Type 2 diabetes
- NCT number
- NCT07045662
What you commit to
- Study type: Interventional
- Participants enrolled: 88
- From Jul 2024 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hearing impairment that compromises communication
- History of serious psychiatric disorder recorded in the medical record
Other
- Pregnancy
- Physical health problems that prevent the patient from coming to the unit
- Cognitive problems according to the MMSE cutoff points
- Patients not located after three attempts of home visits on different days and times
Who the study is looking for
- Clinical diagnosis of Type 2 Diabetes mellitus Disease
- Must be able to read and speak Portuguese
- Being followed exclusively at the primary health care unit for the disease at the beginning of the study
- Not participating in other studies involving diabetes mellitus
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal University of Rio Grande do Sul Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.