Clinical trial NCT04958980: Multiprofessional Approach in Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus
Health education
Multiprofessional team
Collective health
Health promotion
Lead sponsor: Leonardo Paroche de Matos
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of periodontitis associated with diabetes mellitus
timeFrame: 6 months
measure: Risk rate for periodontal disease (in %) associated with diabetes mellitus
timeFrame: 6 months
measure: Association of glycemic control with changes in body weight (in kg)
timeFrame: 6 months
measure: Comparison of glycemic control
timeFrame: 6 months
measure: % of participants at risk for worsening diabetes mellitus
timeFrame: 6 months
measure: % of participants at risk for anemic diseases
timeFrame: 6 months
measure: Concentration of participants at risk for developing kidney complications [urea]
timeFrame: 6 months
measure: Concentration of participants at risk of developing kidney failure
timeFrame: 6 months
measure: Concentration of participants at risk for the development of kidney stones and worsening of diabetes mellitus
timeFrame: 6 months
measure: Concentration of participants at risk for the development of liver complications
timeFrame: 6 months
measure: Concentration of participants at risk for the development of liver failure associated with diabetes mellitus
timeFrame: 6 months
measure: Observation of the risk of developing cardiovascular diseases associated with diabetes mellitus
timeFrame: 6 months
measure: Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus
timeFrame: 6 months
measure: Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus
timeFrame: 6 months
measure: Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency
timeFrame: 6 months
measure: Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus
timeFrame: 6 months
measure: Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus
timeFrame: 6 months
measure: Concentration of participants at increased risk for diabetes complications related to increased waist circumference
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Guarulhos City Hall
name: Lilian Oliveira
role: PRINCIPAL_INVESTIGATOR
References: