Clinical trial NCT05969015: Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Diabetes Mellitus
Keywords: Self Management
Behavior
Type 2 Diabetes Mellitus
Cardiovascular Disease
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
Collaborators: name: Prefeitura Municipal de Criciúma
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS)
name: Hospital Universitário São José
First posted: 2023-08-01
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an effectiveness/pragmatic, parallel-arm, randomized, superiority trial.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Glycemic control
timeFrame: at 3-monthly intervals during 18 month
Secondary outcomes:
measure: Blood Pressure control
timeFrame: at 6-monthly intervals during 18 month
measure: All-cause number of health care settings visits
timeFrame: at 6-monthly intervals during 18 month
measure: Attributable number of health care settings visits to type 2 diabetes mellitus
timeFrame: at 6-monthly intervals during 18 month
measure: Weight
timeFrame: at 6-monthly intervals during 18 month
measure: Height
timeFrame: at 6-monthly intervals during 18 month
measure: Body mass index
timeFrame: at 6-monthly intervals during 18 month
measure: Abdominal circumference
timeFrame: at 6-monthly intervals during 18 month
measure: Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form
timeFrame: at 6-monthly intervals during 18 month
measure: Depression scores by Hamilton Depression Rating Scale - HDR-S
timeFrame: at 6-monthly intervals during 18 month
measure: Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: at 6-monthly intervals during 18 month
measure: MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil
timeFrame: at 6-monthly intervals during 18 month
measure: Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs
timeFrame: at 6-monthly intervals during 18 month
measure: Low density lipoprotein levels - LDL-C
timeFrame: at 3-monthly intervals during 18 month
measure: High density lipoprotein levels - HDL-C
timeFrame: at 3-monthly intervals during 18 month
measure: Total cholesterol levels - TC
timeFrame: at 3-monthly intervals during 18 month
measure: Total triglycerides levels - TG
timeFrame: at 3-monthly intervals during 18 month
measure: Creatinine levels
timeFrame: at 3-monthly intervals during 18 month
measure: Diabetes Mellitus knowledge (DKN-A)
timeFrame: at 6-monthly intervals during 18 month
measure: Diabetes Attitude Questionnaire (ATT-19)
timeFrame: at 6-monthly intervals during 18 month
Other outcomes:
measure: Adverse Events
timeFrame: at 6-monthly intervals during 18 month
Locations:
city: Criciúma
country: Brazil
facility: Universidade do Extremo Sul Catarinense
state: Santa Catarina
city: Criciúma
country: Brazil
facility: Universidade do Extremo Sul Catarinense
state: Santa Catarina
Study officials:
affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Coordinator Committee
name: Luciane B Ceretta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee
name: Cristiane D Tomasi, PhD
role: STUDY_CHAIR
affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee
name: Vanessa IA Miranda, PhD
role: STUDY_DIRECTOR
affiliation: The D-CARE Steering Committee
name: Andriele Vieira, PhD
role: STUDY_DIRECTOR
affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Adjudication/Medical Committee
name: Felipe Dal-Pizzol, MD, PhD
role: STUDY_DIRECTOR
References: