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Type 2 Diabetes Mellitus (T2DM)NCT07045662

Health Literacy in Patients With Type 2 Diabetes Mellitus.

A study testing Multidisciplinary Assessment in people with Type 2 Diabetes Mellitus (T2DM), run by Ernanda Mezaroba at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Multidisciplinary Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteBrazil
Study dates
12 Jul 2024to 30 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of Rio Grande do Sul

    Porto Alegre

Other trials in Brazil

About this study

Official title: Effectiveness of Health Literacy in Patients With Type 2 Diabetes Mellitus on a Primary Health Care Protocol: a Randomized Pragmatic Trial

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.

Read the 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.

Being tested
Multidisciplinary Assessment
Keywords
Health literacy., Type 2 Diabetes Mellitus., Health education., Primary health care., Pragmatic clinical trial.
Medical subject headings
Diabetes Mellitus, Type 2, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary AssessmentBehavioural

    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.

Study groups in NCT07045662
Study groupRoleWhat they receive
Usual AssessmentNo interventionThe participants in the usual assessment were provided regular care, including at least one medical appointment every six months with prescription review.
Multidisciplinary AssessmentActive comparatorThe 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.
Receives: Behavioral: Multidisciplinary Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From enrollment to the end of treatment at 6 months.

Secondary outcomes (4)

  1. Knowledge about diabetes.

    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).

    Measured: From enrollment to the end of treatment at 6 months.

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

    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.

    Measured: From enrollment to the end of treatment at 6 months.

  3. Glycosylated Hemoglobin

    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.

    Measured: From enrollment to the end of treatment at 6 months.

  4. Health conditions

    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)

    Measured: From enrollment to the end of treatment at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start12 Jul 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07045662
Sponsor's protocol ID
CAAE 79433824.3.0000.5347
Status last verified
Jun 2025
First submitted
24 Apr 2025
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At this stage, I do not intend to share the data collected in this study, as it is part of my doctoral thesis and we intend to analyze it for future publication in peer-reviewed scientific journals at first. Moreover, the decision to withhold the data corroborates with the guidelines established by the Research Ethics Committee, which emphasize that such information must remain under the sole responsibility of the researcher.

Publications

  • 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.

    PubMed 23855504

  • 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.

    PubMed 6705664

  • 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.

    PubMed 10457237

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary Assessment in people with Type 2 Diabetes Mellitus (T2DM), run by Ernanda Mezaroba at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health literacy through the use of Health Literacy Questionnaire - HLQ. (time frame: From enrollment to the end of treatment at 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07045662, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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