Multiprofessional Approach in Diabetes Mellitus

NCT ID: NCT04958980

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-03-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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.

Interventions

Specific 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leonardo Paroche de Matos

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Paroche de Matos

main researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lilian Oliveira

Role: PRINCIPAL_INVESTIGATOR

Guarulhos City Hall

Central Contacts

Leonardo Matos

Role: CONTACT

leonardoparoche@gmail.com

5511988000176

Other Identifiers

00129122020

Identifier Type: -

Identifier Source: org_study_id