NCT05969015CompletedNot Applicable
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 Saude3 sites in 1 country174 target enrollmentStarted: January 15, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 174
- Locations
- 3
- Primary Endpoint
- Glycemic control
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes' assessors will be masked to assigned interventions in all measurements they would perform.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (3)
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