Educação em saúde Intensiva na atenção primária à saúde em Pacientes Com Diabetes Mellitus Tipo 2: um Ensaio clínico Randomizado - The Diabetes Care (D-CARE) Study

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude1 site in 1 country174 target enrollmentJanuary 15, 2022

ConditionsDiabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Enrollment: 174
Locations: 1
Primary Endpoint: Glycemic control
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.

Registry

clinicaltrials.gov

Start Date

January 15, 2022

End Date

May 7, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
•To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
•Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
•T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);

Exclusion Criteria

•Pregnant women;
•People living with HIV/AIDS;
•T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
•T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
•T2DM patients with severe eye and retine disease;
•Patients participating in another study simultaneously;
•Patients living with others in the same place.

Outcomes

Primary Outcomes

Glycemic control

Time Frame: at 3-monthly intervals during 18 month

Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)

Secondary Outcomes

Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs(at 6-monthly intervals during 18 month)
All-cause number of health care settings visits(at 6-monthly intervals during 18 month)
Blood Pressure control(at 6-monthly intervals during 18 month)
Body mass index(at 6-monthly intervals during 18 month)
Abdominal circumference(at 6-monthly intervals during 18 month)
High density lipoprotein levels - HDL-C(at 3-monthly intervals during 18 month)
Diabetes Attitude Questionnaire (ATT-19)(at 6-monthly intervals during 18 month)
Attributable number of health care settings visits to type 2 diabetes mellitus(at 6-monthly intervals during 18 month)
Weight(at 6-monthly intervals during 18 month)
Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form(at 6-monthly intervals during 18 month)
Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)(at 6-monthly intervals during 18 month)
Total cholesterol levels - TC(at 3-monthly intervals during 18 month)
Height(at 6-monthly intervals during 18 month)
Depression scores by Hamilton Depression Rating Scale - HDR-S(at 6-monthly intervals during 18 month)
Creatinine levels(at 3-monthly intervals during 18 month)
Low density lipoprotein levels - LDL-C(at 3-monthly intervals during 18 month)
Total triglycerides levels - TG(at 3-monthly intervals during 18 month)
MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil(at 6-monthly intervals during 18 month)
Diabetes Mellitus knowledge (DKN-A)(at 6-monthly intervals during 18 month)