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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 24
- Primary Endpoint
- Comparison of glycemic control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
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.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Placebo
The control group will be evaluated in 2 stages: at the beginning and at the end of the study and will be accompanied only with scheduled medical consultations (also simulating the reality of basic health units with a traditional model of care) and the intervention group will undergo evaluations with the multiprofessional team on two occasions (at the beginning and at the end of the study)
Specific and educational guidelines on pathology care (diabetes mellitus)
Multiprofessional educational guidelines and analysis of the following exams:
- Periodontal record, bleeding rate on and visible plaque;
- Body mass index (BMI): weight (kg) divided by height squared (m²);
- Serum glucose values;
- Glycated hemoglobin;
- Blood count: hemoglobin;
- Urea: male:
- Creatinine male;
- Uric acid;
- Oxalacetic glutamic transaminase;
- Glutamic pyruvic transaminase;
- Total cholesterol and fractions: Cholesterol, Non HDL, LDL, VLDL;
- Triglycerides;
- Type I urine;
- Vitamin D3 25OH;
- Microalbuminuria;
- Blood pressure: systolic;
- Abdominal circumference.
Intervention: Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research (Behavioral)
Outcomes
Primary Outcomes
Comparison of glycemic control
Time Frame: 6 months
Serum glucose values: 80 to 130mg/ dl
% of participants at risk for worsening diabetes mellitus
Time Frame: 6 months
Glycated hemoglobin: \<7%
Concentration of participants at risk for developing kidney complications [urea]
Time Frame: 6 months
Urea: male: \<40mg/ dl, female: \<55mg/ dl
Concentration of participants at risk of developing kidney failure
Time Frame: 6 months
Creatinine male: 0.7-1.30mg/ dl, female: 0.5- 1.10mg/ dl
Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus
Time Frame: 6 months
Blood pressure: systolic- \<130mmHg, diastolic: \<85mHg
incidence of periodontitis associated with diabetes mellitus
Time Frame: 6 months
Periodontal record: up to 3mm.
Risk rate for periodontal disease (in %) associated with diabetes mellitus
Time Frame: 6 months
Bleeding rate on and visible plaque: up to 10%;
Association of glycemic control with changes in body weight (in kg)
Time Frame: 6 months
Body mass index (BMI): weight (kg) divided by height squared (m²);
Concentration of participants at risk for the development of liver complications
Time Frame: 6 months
Oxalacetic glutamic transaminase: male: \<50U/ L, female: \<40U/ L
% of participants at risk for anemic diseases
Time Frame: 6 months
Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl
Concentration of participants at risk for the development of kidney stones and worsening of diabetes mellitus
Time Frame: 6 months
Uric acid: male: 3.4- 7.0mg/ dl, female: 2.4- 7.4mg/ dl
Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus
Time Frame: 6 months
Type I urine: negative proteinuria and glycosuria
Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency
Time Frame: 6 months
Vitamin D3 25OH: \<60y: \>20ng/ dl, \>60y: \>30ng/dl
Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus
Time Frame: 6 months
Microalbuminuria: \<30mg/day
Concentration of participants at increased risk for diabetes complications related to increased waist circumference
Time Frame: 6 months
Abdominal circumference: male: 102cm, female: 88cm
Concentration of participants at risk for the development of liver failure associated with diabetes mellitus
Time Frame: 6 months
Glutamic pyruvic transaminase: male: \<50U/ L, female: \<40U/ L
Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus
Time Frame: 6 months
Triglycerides: \<175mg/ dl
Observation of the risk of developing cardiovascular diseases associated with diabetes mellitus
Time Frame: 6 months
Total cholesterol and fractions: Cholesterol: 190mg/ dl, HDL:\> 40mg/ dl, Non HDL: \<160mg/ dl, LDL: \<100mg/ dl, VLDL: 10- 50mg/ dl
Secondary Outcomes
No secondary outcomes reported
Investigators
Leonardo Paroche de Matos
main researcher
Leonardo Paroche de Matos