Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude174 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

174

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus

Interventions

Prochaska and DiClemente transtheorical modelBEHAVIORAL

The Prochaska and DiClemente model will be combined to a self-management program in patients with T2DM within 18 months. They will be classified accordingly to their readiness for changing. A care provider will manage the group towards an optimal self-management, aiming to improve their glycemic control and other outcomes of relevance. We will conduct 1 session per week until the end of 12nd intervention month. After, the sections will be conducted each 2 weeks until the end of the trial. Healthcare professional will provide support to the care provider. The recommended processes to progress the patients will be used to trigger them accordingly to their stage, at the discretion of the care provider. We will also consider individualities and non-anticipated problems as a part of the process of behavior changing.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

Outcomes

Primary Outcomes

Glycemic control

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

Time frame: at 3-monthly intervals during 18 month

Secondary Outcomes

Blood Pressure control

Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)

Time frame: at 6-monthly intervals during 18 month

All-cause number of health care settings visits

All-cause number of health care settings visits measured by counts

Time frame: at 6-monthly intervals during 18 month

Attributable number of health care settings visits to type 2 diabetes mellitus

Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts

Time frame: at 6-monthly intervals during 18 month

Weight

Anthropometric variables measured in kg

Time frame: at 6-monthly intervals during 18 month

Height

Anthropometric variables -measured in meters

Time frame: at 6-monthly intervals during 18 month

Body mass index

Anthropometric variables - kg per square meter

Time frame: at 6-monthly intervals during 18 month

Abdominal circumference

Anthropometric variables - measured in centimeters (cm)

Time frame: 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

There are three levels of physical activity suggested for classifying populations; these are the new proposed levels, which take account of the concept of total physical activity of all domains. The proposed levels are: inactive; minimally active and HEPA activeí health-enhancing physical activity; a highly active category

Time frame: at 6-monthly intervals during 18 month

Depression scores by Hamilton Depression Rating Scale - HDR-S

A score of 0-7 is generally accepted to be within the normal range (or in clinical emission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

Time frame: at 6-monthly intervals during 18 month

Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)

Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Time frame: at 6-monthly intervals during 18 month

MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil

Qualitative assessment of food intake for the previous day.

Time frame: at 6-monthly intervals during 18 month

Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs

Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients

Time frame: at 6-monthly intervals during 18 month

Low density lipoprotein levels - LDL-C

Serum LDL-C levels in mg/dL

Time frame: at 3-monthly intervals during 18 month

High density lipoprotein levels - HDL-C

Serum HDL-C levels in mg/dL

Time frame: at 3-monthly intervals during 18 month

Total cholesterol levels - TC

Serum TC levels in mg/dL

Time frame: at 3-monthly intervals during 18 month

Total triglycerides levels - TG

Serum TG levels in mg/dL

Time frame: at 3-monthly intervals during 18 month

Creatinine levels

Serum creatinine levels in mg/dL

Time frame: at 3-monthly intervals during 18 month

Diabetes Mellitus knowledge (DKN-A)

The measuring scale used is from 0 to 15. A score of one (1) is attributed to the correct answer and of zero (0) for the incorrect answer. A score higher than eight (8) indicates knowledge about diabetes mellitus

Time frame: at 6-monthly intervals during 18 month

Diabetes Attitude Questionnaire (ATT-19)

ATT-19 is an instrument that seeks to measure psychological adjustment for diabetes mellitus, developed in response to the need for evaluation of the psychological and emotional aspects of the disease. It contains nineteen items that include six factors: a) DM-associated stress, b) treatment receptivity, c) trust in the treatment, d) personal efficiency, e) health perception, and f) social acceptance, with the answers measured using a five-point Likert scale (completely disagree - score 1; up to completely agree - score 5). The total value of the score can vary from 19 to 95 points. A score higher than 70 indicates a positive attitude toward the disease. In this instrument, attitude is related to the decision of the individual to adopt or not the self-care measures for diabetes control.

Time frame: at 6-monthly intervals during 18 month

Data from ClinicalTrials.gov

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