Multiprofessional Approach in Diabetes Mellitus

NCT04958980 | Unknown DMC

• 1 other identifier: 00129122020
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (18)

• incidence of periodontitis associated with diabetes mellitus

  Periodontal record: up to 3mm.

  6 months

• Risk rate for periodontal disease (in %) associated with diabetes mellitus

  Bleeding rate on and visible plaque: up to 10%;

  6 months

• Association of glycemic control with changes in body weight (in kg)

  Body mass index (BMI): weight (kg) divided by height squared (m²);

  6 months

• Comparison of glycemic control

  Serum glucose values: 80 to 130mg/ dl

  6 months

• % of participants at risk for worsening diabetes mellitus

  Glycated hemoglobin: \<7%

  6 months

• % of participants at risk for anemic diseases

  Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl

  6 months

• Concentration of participants at risk for developing kidney complications [urea]

  Urea: male: \<40mg/ dl, female: \<55mg/ dl

  6 months

• Concentration of participants at risk of developing kidney failure

  Creatinine male: 0.7-1.30mg/ dl, female: 0.5- 1.10mg/ dl

  6 months

• Concentration of participants at risk for the development of kidney stones and worsening of diabetes mellitus

  Uric acid: male: 3.4- 7.0mg/ dl, female: 2.4- 7.4mg/ dl

  6 months

• Concentration of participants at risk for the development of liver complications

  Oxalacetic glutamic transaminase: male: \<50U/ L, female: \<40U/ L

  6 months

• Concentration of participants at risk for the development of liver failure associated with diabetes mellitus

  Glutamic pyruvic transaminase: male: \<50U/ L, female: \<40U/ L

  6 months

• Observation of the risk of developing cardiovascular diseases associated with diabetes mellitus

  Total cholesterol and fractions: Cholesterol: 190mg/ dl, HDL:\> 40mg/ dl, Non HDL: \<160mg/ dl, LDL: \<100mg/ dl, VLDL: 10- 50mg/ dl

  6 months

• Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus

  Triglycerides: \<175mg/ dl

  6 months

• Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus

  Type I urine: negative proteinuria and glycosuria

  6 months

• Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency

  Vitamin D3 25OH: \<60y: \>20ng/ dl, \>60y: \>30ng/dl

  6 months

• Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus

  Microalbuminuria: \<30mg/day

  6 months

• Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus

  Blood pressure: systolic- \<130mmHg, diastolic: \<85mHg

  6 months

• Concentration of participants at increased risk for diabetes complications related to increased waist circumference

  Abdominal circumference: male: 102cm, female: 88cm

  6 months

Study Arms (2)

Placebo

NO INTERVENTION

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)

ACTIVE COMPARATOR

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.

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

Interventions

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

Specific and educational guidelines on pathology care (diabetes mellitus)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leonardo Paroche de Matos: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lilian Oliveira

  Guarulhos City Hall

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo Matos

CONTACT

5511988000176; leonardoparoche@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: main researcher

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: July 12, 2021
• Study Start: August 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share