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Multiprofessional Approach in Diabetes Mellitus

The Effectiveness of the Multiprofessional Approach in an Educational Group in the Control of Diabetes Mellitus in Patients Using Oral Hypoglycemic Agents From a Basic Health Unit in the City of Guarulhos/ SP: a Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04958980
Enrollment
24
Registered
2021-07-12
Start date
2021-08-31
Completion date
2022-03-31
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus, Health education, Multiprofessional team, Collective health, Health promotion

Brief summary

OBJECTIVE: to verify the effectiveness of adopting the practice of educational groups in primary care and the multiprofessional role in the control of diabetes mellitus in adults. METHODOLOGY: a randomized clinical study carried out in an educational group at the Basic Health Unit Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users in the control group and 12 users in the control group. study (which will receive the interventions of the multidisciplinary team) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of the multidisciplinary action in the control of diabetes mellitus.

Detailed description

INTRODUCTION: diabetes mellitus is highlighted as an obstacle in health equipment because it is a chronic disease and has a high mortality rate. The pathology results in hyperglycemia, disorders or insufficiency of several organs. OBJECTIVE: to verify the effectiveness of adopting the practice of educational groups in primary care and the multidisciplinary role in the control of diabetes mellitus in adults. THEORETICAL BACKGROUND: type II diabetes mellitus (type II DM) is a pathology that represents a high risk for cardiovascular, renal, ophthalmological complications and in several other systems. It is considered a major issue to be controlled by health services, as the high cost of treatments related to the sequelae of type II DM, as well as high rates of hospitalizations and associated therapies have been increasing and decompensating public budgets. Primary care has a fundamental role in preventing the disease and associated complications. METHODOLOGY: randomized clinical study conducted in an educational group at the Basic Health Unit Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users in the control group and 12 users in the group study (which will receive the interventions of the multidisciplinary team) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of the multidisciplinary performance in the control of diabetes mellitus. RESULTS: the participants are expected to show improvements in the control of the pathology and awareness about the relevance of self-care, facts that will be observed through laboratory data and subsequent multi-professional evaluations.

Interventions

BEHAVIORALSpecific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research

Physician: Guidance on pathology, sequelae and treatment, as well as guidance on the importance of medical monitoring. Dental surgeon: guidance on oral health, demonstration of brushing techniques and daily flossing and periodontal changes resulting from diabetes mellitus. Nurse: Guidance on pathology prioritizing pathophysiology, self-care and skin care and wound prevention (vascular sequelae). Nutritionist: nutritional guidelines on diabetes mellitus and healthy eating habits. Physiotherapist: guidance on prevention of falls and injuries and health promotion. Physical educator: guidance on the importance of practicing physical activities for general health, encouraging self-care and body awareness and demonstrating basic physical activities that can be performed at home.

Sponsors

Leonardo Paroche de Matos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

The formation of randomized groups will occur by random drawing, obeying the proportion of 1: 1 in both groups, that is, 12 participants in each group (control and intervention) that will be selected after the screening carried out by the research nurse (to verify some possible exclusion criteria for research participants), reducing the occurrence of methodological bias in the sampling phase and ensuring the possibility that all participants can be included in the intervention group.

Intervention model description

randomized clinical study conducted in an educational group at the Basic Health Unit of Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users of the control group and 12 users of the study group (who will receive the researchers' interventions) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of multiprofessional action in the control of diabetes mellitus.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 24 on-insulin-dependent type II diabetes patients (users of oral hypoglycemic agents), * over 18 years of age, * both sexes, * with no restrictions on physical exercise (found after medical evaluation) * who agreed to participate voluntarily in the study (after signature of the Free and Informed Consent Form) * of a specific area of the Family Health Strategy - chosen by the proximity to the Basic Health Unit.

Exclusion criteria

* Patients with associated pathologies: cardiovascular conditions: Congestive Heart Failure,Decompensated Systemic Arterial Hypertension, Sequela of Acute Myocardial Infarction * Cancer patients, * Respiratory conditions: Chronic Obstructive Pulmonary Disease, Severe asthma and any other disabling lung condition. * Endocrine conditions that aggravate diabetes mellitus: Pancreatic pathologies (pancreatitis, pancreatic cysts, obstructions and pancreatic cancer) * Patients with impaired vision, * Motor or balance disorders, * With any special needs (physical or intellectual), * With consequences resulting from the evolution of type II diabetes mellitus * Users who refused to participate in the research.

Design outcomes

Primary

MeasureTime frameDescription
incidence of periodontitis associated with diabetes mellitus6 monthsPeriodontal record: up to 3mm.
Risk rate for periodontal disease (in %) associated with diabetes mellitus6 monthsBleeding rate on and visible plaque: up to 10%;
Association of glycemic control with changes in body weight (in kg)6 monthsBody mass index (BMI): weight (kg) divided by height squared (m²);
Comparison of glycemic control6 monthsSerum glucose values: 80 to 130mg/ dl
% of participants at risk for worsening diabetes mellitus6 monthsGlycated hemoglobin: \<7%
% of participants at risk for anemic diseases6 monthsBlood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl
Concentration of participants at risk for developing kidney complications [urea]6 monthsUrea: male: \<40mg/ dl, female: \<55mg/ dl
Concentration of participants at risk of developing kidney failure6 monthsCreatinine male: 0.7-1.30mg/ dl, female: 0.5- 1.10mg/ dl
Concentration of participants at risk for the development of kidney stones and worsening of diabetes mellitus6 monthsUric acid: male: 3.4- 7.0mg/ dl, female: 2.4- 7.4mg/ dl
Concentration of participants at risk for the development of liver complications6 monthsOxalacetic glutamic transaminase: male: \<50U/ L, female: \<40U/ L
Concentration of participants at risk for the development of liver failure associated with diabetes mellitus6 monthsGlutamic pyruvic transaminase: male: \<50U/ L, female: \<40U/ L
Observation of the risk of developing cardiovascular diseases associated with diabetes mellitus6 monthsTotal cholesterol and fractions: Cholesterol: 190mg/ dl, HDL:\> 40mg/ dl, Non HDL: \<160mg/ dl, LDL: \<100mg/ dl, VLDL: 10- 50mg/ dl
Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus6 monthsTriglycerides: \<175mg/ dl
Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus6 monthsType I urine: negative proteinuria and glycosuria
Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency6 monthsVitamin D3 25OH: \<60y: \>20ng/ dl, \>60y: \>30ng/dl
Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus6 monthsMicroalbuminuria: \<30mg/day
Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus6 monthsBlood pressure: systolic- \<130mmHg, diastolic: \<85mHg
Concentration of participants at increased risk for diabetes complications related to increased waist circumference6 monthsAbdominal circumference: male: 102cm, female: 88cm

Contacts

Primary ContactLeonardo Matos
leonardoparoche@gmail.com5511988000176

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026