Health Literacy in Patients With Type 2 Diabetes Mellitus.

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT07045662
• Lead Sponsor: Ernanda Mezaroba

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.

Study Timeline

• Study Start: 2024-07-12
• Study First Submitted: 2025-04-24
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-22
• Last Update Submitted: 2025-06-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health literacy through the use of Health Literacy Questionnaire - HLQ.	From enrollment to the end of treatment at 6 months.	The HLQ (Osborne et al.,2013) consists of 9 scales representing 9 dimensions of health literacy: Feeling understood and supported by healthcare providers; Having sufficient information to manage my health;Actively managing my health;Social support for health;Appraisal of health information;Ability to actively engage with healthcare providers;Navigating the healthcare system;Ability to find good health information;Understand health information well enough to know what to do.; Each HLQ scale has 4-6 items. The HLQ does not provide one overall summative score. The scoring of the HLQ is 9 scale scores, calculated by averaging the item scores within each scale with equal weighting. The 9 scale scores will reflect a person's strengths and needs in the different dimensions of health literacy, with higher scores meaning greater health literacy.; For Scales 1 to 5, the score range is between 1 and 4 (4 response options). For Scales 6 to 9, the score range is between 1 and 5 (5 response options).

Secondary Outcome Measures

Name	Time	Method
Health conditions	From enrollment to the end of treatment at 6 months.	The health conditions questionnaire includes the following items: - Presence of diseases associated with DM: Eye problems Kidney problems Blood circulation problems Foot problems Other; - Presence of other morbidities: High blood pressure Obesity Chronic kidney disease Heart disease Depression Anxiety disorder Hypothyroidism Hyperthyroidism Fibromyalgia Cancer Asthma Hypercholesterolemia Cartilage/bone inflammation/degeneration Other; - Smoking: Yes No; - Use of alcoholic beverages: Yes No; - Practice of physical activity: Yes No; - Body mass index: Underweight: BMI less than 18.5 kg/m² Normal weight: BMI between 18.5 and 24.9 kg/m² Overweight: BMI between 25 and 29.9 kg/m² Obesity: defined as a BMI ≥ 30 kg/m²; - Abdominal circumference (reference values): Women: ≤ 80 cm Men: ≤ 94 cm; - Number of consultations with nurses, physicians, and nutritionists over the past six months (assessed only in the second data collection phase)
Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus	From enrollment to the end of treatment at 6 months.	Self-efficacy will be assessed using the Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus (DMSES). The DMSES has 20 items, distributed across four factors (specific nutrition and weight; general nutrition and drug treatment; physical exercise; blood glucose). The scale items describe the behaviors that people with DM should perform for each of the aforementioned care practices and ask whether they feel able to perform these practices (Bijl; Poelgeest-Eeltink; Shortridge-Baggett, 1999). A Likert-type scale is used to respond to each item, with the following response and scoring pattern: definitely yes (5 points); probably yes (4 points); don't know (3 points); probably no (2 points); definitely no (1 point). SE is determined by the overall mean of the instrument: the scores for each item are added together and divided by the number of items. Higher means indicate greater self-efficacy.
Knowledge about diabetes.	From enrollment to the end of treatment at 6 months.	Knowledge about DM will be measured by the Diabetes Knowledge Scale (DKN-A). The DKN-A, with 15 multiple-choice questions, addresses several aspects related to general knowledge of diabetes, through 5 categories: a) basic physiology, including the action of insulin; b) hypoglycemia; c) food groups and their replacements; d) management of diabetes in the presence of another disease; e) general principles for disease care. The measurement scale is 0-15 and each item has the following score: one (1) for a correct answer and zero (0) for an incorrect answer. Items 1 to 12 require a single correct answer. For questions 13 to 15, two answers are correct and both must be correct to obtain a score of one. A score of 0 to 8 points indicates little knowledge and greater than 8 points indicates good knowledge about diabetes (Dunn et al., 1984).
Glycosylated Hemoglobin	From enrollment to the end of treatment at 6 months.	Glycosylated hemoglobin (HbA1c) is a blood test that measures the average blood glucose levels over the last 3 to 4 months and is routinely used to assess glycemic control in people with diabetes. The target HbA1c result for people with diabetes is around 7.0%, however it varies according to age and presence of comorbidities. Higher values indicate that blood glucose levels are not adequate.

Trial Locations

Locations (1)

Federal University of Rio Grande do Sul; 🇧🇷 Porto Alegre, Brazil