Health Literacy in Patients With Type 2 Diabetes Mellitus.

NCT07045662 | Active Not Recruiting DMC

• 1 other identifier: CAAE 79433824.3.0000.5347
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Health literacy.; Type 2 Diabetes Mellitus.; Health education.; Primary health care.; Pragmatic clinical trial.

Outcome Measures

Primary Outcomes (1)

• Health literacy through the use of Health Literacy Questionnaire - HLQ.

  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).

  From enrollment to the end of treatment at 6 months.

Secondary Outcomes (4)

• Knowledge about diabetes.

  From enrollment to the end of treatment at 6 months.

• Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus

  From enrollment to the end of treatment at 6 months.

• Glycosylated Hemoglobin

  From enrollment to the end of treatment at 6 months.

• Health conditions

  From enrollment to the end of treatment at 6 months.

Study Arms (2)

Usual Assessment

NO INTERVENTION

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

Multidisciplinary Assessment

ACTIVE COMPARATOR

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.

Behavioral: Multidisciplinary Assessment

Interventions

Multidisciplinary Assessment 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.

Multidisciplinary Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ernanda Mezaroba: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Brazil

Location

Related Publications (3)

• 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.

  PMID: 23855504 BACKGROUND

• 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.

  PMID: 6705664 BACKGROUND

• 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.

  PMID: 10457237 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Health Education

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Idiane Rosset, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: July 1, 2025
• Study Start: July 12, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)