Health Literacy in Patients With Type 2 Diabetes Mellitus.

NCT ID: NCT07045662

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2025-06-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Assessment

The participants in the usual assessment were provided regular care, including at least one medical appointment every six months with prescription review.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multidisciplinary Assessment

The participants in the multidisciplinary assessment were followed by 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.

Group Type: ACTIVE_COMPARATOR

Multidisciplinary Assessment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnancy
• Physical health problems that prevent the patient from coming to the unit
• Hearing impairment that compromises communication
• Cognitive problems according to the MMSE cutoff points
• History of serious psychiatric disorder recorded in the medical record
• Patients not located after three attempts of home visits on different days and times

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Ernanda Mezaroba

OTHER

Sponsor Role: lead

Responsible Party

Ernanda Mezaroba

PhD student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Idiane Rosset, PhD

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Locations

Federal University of Rio Grande do Sul

Porto Alegre, , Brazil

Countries

Brazil

References

Osborne RH, Batterham RW, Elsworth GR, Hawkins M, Buchbinder R. The grounded psychometric development and initial validation of the Health Literacy Questionnaire (HLQ). BMC Public Health. 2013 Jul 16;13:658. doi: 10.1186/1471-2458-13-658.

Reference Type: BACKGROUND

PMID: 23855504 (View on PubMed)

Dunn SM, Bryson JM, Hoskins PL, Alford JB, Handelsman DJ, Turtle JR. Development of the diabetes knowledge (DKN) scales: forms DKNA, DKNB, and DKNC. Diabetes Care. 1984 Jan-Feb;7(1):36-41. doi: 10.2337/diacare.7.1.36.

Reference Type: BACKGROUND

PMID: 6705664 (View on PubMed)

Bijl JV, Poelgeest-Eeltink AV, Shortridge-Baggett L. The psychometric properties of the diabetes management self-efficacy scale for patients with type 2 diabetes mellitus. J Adv Nurs. 1999 Aug;30(2):352-9. doi: 10.1046/j.1365-2648.1999.01077.x.

Reference Type: BACKGROUND

PMID: 10457237 (View on PubMed)

Other Identifiers

CAAE 79433824.3.0000.5347

Identifier Type: -

Identifier Source: org_study_id