Evaluation of a Health Education Program for Type 2 Diabetes Patients (EDUCA-DM)

July 30, 2024 updated by: Association for Innovation and Biomedical Research on Light and Image

The goal of this, Retrospective and Prospective Low- Interventional study, is to implement health education interventions to promote self-care and reduce disease complications in DM Type 2 patients at higher risk of development/progression of Diabetic Retinopathy. ]. The main question it aims to answer are:

  • To evaluate the impact of a health education intervention on mental health, self-care behaviors, and disease knowledge in patients with Diabetes Mellitus Type 2 with high risk of development/progression of Diabetic Retinopathy.
  • To evaluate the impact of a health education intervention on the metabolic control of patients with Diabetes Mellitus Type 2 with high risk of development/progression of Diabetic Retinopathy.

Patients will have to (V1 and V4):

  • answer three questionnaires, (Summary of Diabetes Self-Care Activities - SDSCA, QCD- Diabetes Knowledge Questionnaire and Depression Anxiety and Stress Scale" (DASS-21).
  • measurement of weight and height, to calculate BMI.
  • collection of glycated hemoglobin analysis (if they have been done in the last 3 months).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic retinopathy (DR) is the most frequent complication of Diabetes mellitus and the main cause of legal blindness in working populations in industrialized countries.

A diagnosis of diabetes has important implications for individuals, not only for their health, but also because of the stigma that a diagnosis can bring, i.e., it can affect employment, quality of life, mental health, social opportunities, and other cultural aspects. These changes in the lives of diabetics can lead to stress. It is known that diabetes has a social and family connotation that leads to depression and anxiety appearing in parallel, which can influence the self-management that people must do in their daily lives. It is necessary to incorporate and integrate mental health care into all diabetic care.

Individuals with diabetes have difficulties: diagnosis, adherence to treatment, fear of complications and hypoglycemia, which can result in suffering, thus making self-management difficult.

In diabetic patients, the prevalence of symptoms of depression and anxiety is about two to four times higher than in the general population. Metabolic dysregulation influences brain function and disturbances in glucose regulation may be associated with depression. These emotions that arise can be disabling and very strong, leading the individual to often acquire behaviors that do not help in fighting the disease. There may be changes in eating behavior, or alcoholic beverages that are not favorable to glycemic control, that is, glycaemia rises proportionally to the most negative events in life, thus, stress leads to an increase in corticosteroids and consequently increases glycaemia. It is known that physical activity can reduce disease rates, namely diabetes, hypertension, obesity, among others. There are studies that show that physical activity is beneficial, whatever its intensity. It reduces the admission of chronically ill patients to hospitals, reduces pain and increases mental health and quality of life. With the development of physical activity programs applied to chronically ill patients, they are beneficial to promote the management of their disease, physical and mental health, and reduce the appearance of other comorbidities. In Diabetes Mellitus, the causes are complex, and its complications can be prevented with a healthy diet, normal blood glucose, adequate weight, and physical activity. For health professionals, who deal with these chronically ill patients, they have a huge challenge, since these people present risk behaviors (unhealthy eating and/or sedentary lifestyle). To assess the disease, there is glycosylated hemoglobin (HbA1c), which reflects the average blood glucose. It is used as a risk parameter and considered the gold standard for assessing glycemic control. The American Diabetes Association (ADA) sets HbA1c < 7% as the threshold of good control for most people with diabetes. To improve glycemic control, nutritional monitoring is important. Nutrition education is considered a preventive and treatment strategy to provide diabetic people with the necessary tools to face the change in lifestyle and achieve self-management of the disease. For this, it is necessary to increase knowledge, acquisition of skills, as well as promote the modification of attitudes and behaviors. It is important to increase people's active participation in the control and treatment of their disease.

Diabetics should participate in self-care education actions with the body, to improve the knowledge, skills, and abilities necessary for the self-care of this pathology.

Based on the evidence collected at the EYEMARKER (NCT02500862), CEC/009/17 study "Characterization of potential biomarkers of Eye Disease and Vision Loss", (ongoing at AIBILI), and STAR screening program "Development of a Model for Advanced Screening for Timely Treatment of Age-Related Eye Diseases", CEC/008/16, it was observed from the beginning the existence of individuals with DM who need clarification and education about their condition and about the care and behaviors to adopt to have a better management of their disease and avoid possible complications. With this study, it is intended to identify, in EYEMARKER patients who also participate in the STAR screening program, which individuals with Diabetes Mellitus are at greater risk of progression/development of Diabetic Retinopathy (DR), to better direct health education plans to reduce disease complications. The identification of patients at higher risk, who will be the target of health promotion actions, will be done through the "RetinaRisk" mobile phone application. After this analysis, 27 individuals who are at greater risk will be chosen. Self-care, knowledge about Diabetes Mellitus disease, emotional state, and metabolic control will be evaluated, before and after the health education sessions.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-548
        • AIBILI-CEC (AIBILI- Clinical Trials Centre)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with type 2 DM participating in STAR (CEC/008/16) and EYEMARKER (CEC/009/17)
  • Higher risk patients through the RetinaRisk ® app ≥ 3%
  • Age ≥50 years
  • Body mass index (IMC) ≥ 25;
  • Glycated hemoglobin (HbA1C): ≥6.5%; (7)
  • Arterial hypertension (HTA): ≥ 139-89 (8)
  • Presence of mild to moderate NPDR with presence of visible retina lesions (microaneurysms, hemorrhages, hard exudates and soft exudates)
  • Subjects capable of understanding the information about the study and giving their informed consent to enter the study.
  • Subjects willing and able to comply with the study.

Exclusion Criteria:

  • Type 1 DM
  • Moderately Severe NPDR;
  • Presence of DME or PDR
  • Other retinal vascular diseases than DR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Health education sessions for type 2 diabetic patients

Patients will be pre-selected according to their risk of developing DR. It will be done through the Retina Risk® application. Will be invited to participate and followed. Retrospective and prospective data will be collected on medical and ophthalmological history (HbA1c value, if performed. 3 questionnaires will be carried out: DM disease, self-care, and emotional state, before and after awareness intervention about self-care through educational sessions in areas of greatest need (physical activity, nutrition, mental health, and self-care). The impact of the previously described sessions on the patients' health status will be assessed using 2 methods: By telephone and by physical examination. Repetition of the 3 questionnaires applied in V1.

The Interventions will be made, through information sessions on the topics: mental health, nutrition, physical exercise, and care that diabetics must take to take care of their body.
Other: health educational sessions in diabetic patients type 2.
Professionals from different areas will be invited to carry out the sessions at Visit 2, namely on: mental health, physical activity, nutrition and self-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression, Anxiety, and Stress Scale-21 (DASS-21)
Time Frame: 3 months

total and subscales scores (depression; anxiety; stress) three months after the health education intervention training sessions. The scale score,(lower scores mean a better result), (the minimum and maximum values): 0 - Nothing applied to me

  1. - It applied to me a few times
  2. - It has applied to me many times
  3. - It applied to me most of the time
3 months
Change in the Summary of Diabetes Self-Care Activities (SDSCA)
Time Frame: 3 months

total and subscales scores (general diet; specific diet; exercise; blood-glucose testing; foot-care; smoking) three months after the health education intervention training sessions.

The scale used is number of days (from 0 to 7)
3 months
Change in the Diabetes Knowledge Questionnaire (DKQ - Portuguese version)
Time Frame: 3 months

Subscales scores (treatment, control and complications; causes; duration) three months after the health education intervention training sessions.

This consists of 20 items distributed by three dimensions (Treatment, control and complications, Causes and Duration).The minimum and maximum values is 0-100, the 0 is minimum and 100 is maximum
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the change in the blood HbA1C level
Time Frame: 3 months

Measure the change in the blood HbA1C level after the health education intervention training sessions.

The unit of measurement for HbA1c is in percentage (%).
3 months
Measure the change in BMI
Time Frame: 3 months

Measure the change in BMI after the health education intervention training sessions.

The unit of measurement for BMI is expressed in units of kg/m2 (weight in kilograms and height in meters).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

March 29, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC/013/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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