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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Prochaska and DiClemente transtheorical model


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an effectiveness/pragmatic, parallel-arm, randomized, superiority trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavior-changing/Self-Management<br>This arm is composed by group-based interventions aiming to modify the self-management of the patients through the Prochaska and DiClemente transtheorical model. It is composed by weekly meetings, lasting up to 1 hour and a half, targeting eight patients per group. After the 12nd month of intervention, the meetings will be held each fifteen days untill the trial ending (18 months). The meetings will deal with lifestyle matters, such as nutrition, weight management, and physical activity, as well as medication adherence, blood glucose testing, and others. Whenever a care provider will be assigned to a group, he/she will go over untill the final of the trial, unless unexpected motivations appear. Patients achieving maintenance will receive green flag from the group-based interventions to avoid contamination. It is up to the care provider to perceive the readiness of the patient to another stage. | Behavioral: Prochaska and DiClemente transtheorical model<br>* 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.<br>|
| No Intervention: Usual Care<br>Patients randomized to the usual care group will follow the same schedule of the experimental group for outcome assessment; however, the trial team will not intervene in the group - i.e., the group will continue their care routine in their primary care unit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%) | at 3-monthly intervals during 18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure control | Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg) | 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 | 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 | at 6-monthly intervals during 18 month | 
| Weight | Anthropometric variables measured in kg | at 6-monthly intervals during 18 month | 
| Height | Anthropometric variables -measured in meters | at 6-monthly intervals during 18 month | 
| Body mass index | Anthropometric variables - kg per square meter | at 6-monthly intervals during 18 month | 
| Abdominal circumference | Anthropometric variables - measured in centimeters (cm) | 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 | 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. | 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. | 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. | 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 | at 6-monthly intervals during 18 month | 
| Low density lipoprotein levels - LDL-C | Serum LDL-C levels in mg/dL | at 3-monthly intervals during 18 month | 
| High density lipoprotein levels - HDL-C | Serum HDL-C levels in mg/dL | at 3-monthly intervals during 18 month | 
| Total cholesterol levels - TC | Serum TC levels in mg/dL | at 3-monthly intervals during 18 month | 
| Total triglycerides levels - TG | Serum TG levels in mg/dL | at 3-monthly intervals during 18 month | 
| Creatinine levels | Serum creatinine levels in mg/dL | 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 | 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. | at 6-monthly intervals during 18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self Management, Behavior, Type 2 Diabetes Mellitus, Cardiovascular Disease