xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05969015</url>
    </required_header>
    <id_info>
      <org_study_id>5.011.600</org_study_id>
      <nct_id>NCT05969015</nct_id>
    </id_info>
    <brief_title>Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study</brief_title>
    <acronym>D-CARE</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Prefeitura Municipal de Criciúma</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Universitário São José</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually&#xD;
        attributable to cardiovascular (CVD) causes. A major concern about the disease is that the&#xD;
        success of the treatment is highly dependent on self-management, which very often incurs the&#xD;
        necessity of behavior change. However, modifying such behaviors, usually linked to daily-life&#xD;
        activities, is challenging. Then, the investigators aimed to test the optimal self-management&#xD;
        that could be achieved in a reasonable manner carried forward through the Prochaska and&#xD;
        DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care.&#xD;
        Our primary outcome is the between-group difference in HbA1c (%) levels.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 15, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This is an effectiveness/pragmatic, parallel-arm, randomized, superiority trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcomes' assessors will be masked to assigned interventions in all measurements they would perform.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Glycemic control</measure>
      <time_frame>at 3-monthly intervals during 18 month</time_frame>
      <description>Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood Pressure control</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause number of health care settings visits</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>All-cause number of health care settings visits measured by counts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attributable number of health care settings visits to type 2 diabetes mellitus</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Anthropometric variables measured in kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Anthropometric variables -measured in meters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Anthropometric variables - kg per square meter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Abdominal circumference</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Anthropometric variables - measured in centimeters (cm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression scores by Hamilton Depression Rating Scale - HDR-S</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where &lt;17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Qualitative assessment of food intake for the previous day.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low density lipoprotein levels - LDL-C</measure>
      <time_frame>at 3-monthly intervals during 18 month</time_frame>
      <description>Serum LDL-C levels in mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High density lipoprotein levels - HDL-C</measure>
      <time_frame>at 3-monthly intervals during 18 month</time_frame>
      <description>Serum HDL-C levels in mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total cholesterol levels - TC</measure>
      <time_frame>at 3-monthly intervals during 18 month</time_frame>
      <description>Serum TC levels in mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total triglycerides levels - TG</measure>
      <time_frame>at 3-monthly intervals during 18 month</time_frame>
      <description>Serum TG levels in mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Creatinine levels</measure>
      <time_frame>at 3-monthly intervals during 18 month</time_frame>
      <description>Serum creatinine levels in mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetes Mellitus knowledge (DKN-A)</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetes Attitude Questionnaire (ATT-19)</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse Events</measure>
      <time_frame>at 6-monthly intervals during 18 month</time_frame>
      <description>Adverse Events as counts: all-cause mortality, cardiovascular mortality, STEMI and non-STEMI (fatal and non-fatal), heart failure diagnosis, unstable angina hospitalizations, cardiovascular procedures, hospital admission or re-admission, chronic kidney disease, retinopathy diagnosis, falls.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">384</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Cardiovascular Diseases</condition>
    <condition>Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Behavior-changing/Self-Management</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prochaska and DiClemente transtheorical model</intervention_name>
      <description>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.</description>
      <arm_group_label>Behavior-changing/Self-Management</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or&#xD;
               taking at least one oral hypoglycaemic agent, or medical diagnosis);&#xD;
  &#xD;
            -  To be regularly assisted by the Sistema Único de Saúde and to have been saw at least&#xD;
               one year before randomization;&#xD;
  &#xD;
            -  Readiness for behavior-changing within the pre-action stages: pre-contemplation,&#xD;
               contemplation and preparation;&#xD;
  &#xD;
            -  T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures,&#xD;
               cardiovascular disease (CVD), etc.);&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women;&#xD;
  &#xD;
            -  People living with HIV/AIDS;&#xD;
  &#xD;
            -  T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and&#xD;
               severe anaemia;&#xD;
  &#xD;
            -  T2DM patients with CVD under non-optimized treatment; or those that made any CVD&#xD;
               procedure; or CVD event (e.g., myocardial infarction) within three months before&#xD;
               randomization;&#xD;
  &#xD;
            -  T2DM patients with severe eye and retine disease;&#xD;
  &#xD;
            -  Patients participating in another study simultaneously;&#xD;
  &#xD;
            -  Patients living with others in the same place.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Luciane B Ceretta, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidade do Extremo Sul Catarinense, The D-CARE Coordinator Committee</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cristiane D Tomasi, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Vanessa IA Miranda, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Andriele Vieira, PhD</last_name>
      <role>Study Director</role>
      <affiliation>The D-CARE Steering Committee</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Felipe Dal-Pizzol, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Universidade do Extremo Sul Catarinense, The D-CARE Adjudication/Medical Committee</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Luciane B Ceretta, PhD</last_name>
      <phone>+55 48 3431 2600</phone>
      <email>luk@unesc.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cristiane D Tomasi, PhD</last_name>
      <phone>+55 48 3431 2609</phone>
      <email>cdtomasi@unesc.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Universidade do Extremo Sul Catarinense</name>
        <address>
          <city>Criciúma</city>
          <state>Santa Catarina</state>
          <zip>88806-000</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Cristiane D Tomasi, PhD</last_name>
        <phone>+55 48 3431 2609</phone>
        <email>cdtomasi@unesc.net</email>
      </contact>
      <contact_backup>
        <last_name>Vanessa IA Miranda, PhD</last_name>
        <phone>+55 48 3431 2609</phone>
        <email>vanessairi@unesc.net</email>
      </contact_backup>
      <investigator>
        <last_name>Luciane B Ceretta, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Andriele Vieira, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Felipe Dal-Pizzol, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Universidade do Extremo Sul Catarinense</name>
        <address>
          <city>Criciúma</city>
          <state>Santa Catarina</state>
          <zip>88806000</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andriele Vieira, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Self Management</keyword>
    <keyword>Behavior</keyword>
    <keyword>Type 2 Diabetes Mellitus</keyword>
    <keyword>Cardiovascular Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will work under individual participant data sharing policy in this study. Third parties interest in should contact the D-CARE Study staff. The IPD Data Sharing Statement is disclosed clearly to patients in our informed consent and also was approved by the responsible IRB. The data will be shared in a deidentified manner, altogether with dictionaries, glossaries, statistical/analytic codes and materials. Authors should provide a proposal that should include the merit, objectives, ethical duties and a data safety plan. For further details please contact the IPD data-sharing committee of the D-CARE Study.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After 6 months after the release of the main report of the study up with no constraints in the upper limit.</ipd_time_frame>
      <ipd_access_criteria>Under the auspicious of the IPD and steering committee of the D-CARE Study.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05969015
  org study id: 5.011.600
  nct id: NCT05969015
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is an effectiveness/pragmatic, parallel-arm, randomized, superiority trial.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Outcomes' assessors will be masked to assigned interventions in all measurements they would perform.
  measure: Glycemic control
  time frame: at 3-monthly intervals during 18 month
  description: Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)
  measure: Blood Pressure control
  time frame: at 6-monthly intervals during 18 month
  description: Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)
  measure: All-cause number of health care settings visits
  time frame: at 6-monthly intervals during 18 month
  description: All-cause number of health care settings visits measured by counts
  measure: Attributable number of health care settings visits to type 2 diabetes mellitus
  time frame: at 6-monthly intervals during 18 month
  description: Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts
  measure: Weight
  time frame: at 6-monthly intervals during 18 month
  description: Anthropometric variables measured in kg
  measure: Height
  time frame: at 6-monthly intervals during 18 month
  description: Anthropometric variables -measured in meters
  measure: Body mass index
  time frame: at 6-monthly intervals during 18 month
  description: Anthropometric variables - kg per square meter
  measure: Abdominal circumference
  time frame: at 6-monthly intervals during 18 month
  description: Anthropometric variables - measured in centimeters (cm)
  measure: Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form
  time frame: at 6-monthly intervals during 18 month
  description: 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
  measure: Depression scores by Hamilton Depression Rating Scale - HDR-S
  time frame: at 6-monthly intervals during 18 month
  description: 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.
  measure: Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)
  time frame: at 6-monthly intervals during 18 month
  description: 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.
  measure: MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil
  time frame: at 6-monthly intervals during 18 month
  description: Qualitative assessment of food intake for the previous day.
  measure: Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs
  time frame: at 6-monthly intervals during 18 month
  description: Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients
  measure: Low density lipoprotein levels - LDL-C
  time frame: at 3-monthly intervals during 18 month
  description: Serum LDL-C levels in mg/dL
  measure: High density lipoprotein levels - HDL-C
  time frame: at 3-monthly intervals during 18 month
  description: Serum HDL-C levels in mg/dL
  measure: Total cholesterol levels - TC
  time frame: at 3-monthly intervals during 18 month
  description: Serum TC levels in mg/dL
  measure: Total triglycerides levels - TG
  time frame: at 3-monthly intervals during 18 month
  description: Serum TG levels in mg/dL
  measure: Creatinine levels
  time frame: at 3-monthly intervals during 18 month
  description: Serum creatinine levels in mg/dL
  measure: Diabetes Mellitus knowledge (DKN-A)
  time frame: at 6-monthly intervals during 18 month
  description: 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
  measure: Diabetes Attitude Questionnaire (ATT-19)
  time frame: at 6-monthly intervals during 18 month
  description: 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.
  measure: Adverse Events
  time frame: at 6-monthly intervals during 18 month
  description: Adverse Events as counts: all-cause mortality, cardiovascular mortality, STEMI and non-STEMI (fatal and non-fatal), heart failure diagnosis, unstable angina hospitalizations, cardiovascular procedures, hospital admission or re-admission, chronic kidney disease, retinopathy diagnosis, falls.
  arm group label: Behavior-changing/Self-Management
  arm group type: Experimental
  description: 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.
  arm group label: Usual Care
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Prochaska and DiClemente transtheorical model
  description: 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.
  arm group label: Behavior-changing/Self-Management
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Luciane B Ceretta, PhD
  role: Principal Investigator
  affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Coordinator Committee
  last name: Cristiane D Tomasi, PhD
  role: Study Chair
  affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee
  last name: Vanessa IA Miranda, PhD
  role: Study Director
  affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee
  last name: Andriele Vieira, PhD
  role: Study Director
  affiliation: The D-CARE Steering Committee
  last name: Felipe Dal-Pizzol, MD, PhD
  role: Study Director
  affiliation: Universidade do Extremo Sul Catarinense, The D-CARE Adjudication/Medical Committee
  last name: Luciane B Ceretta, PhD
  phone: +55 48 3431 2600
  email: luk@unesc.net
  last name: Cristiane D Tomasi, PhD
  phone: +55 48 3431 2609
  email: cdtomasi@unesc.net
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Yes
  ipd description: We will work under individual participant data sharing policy in this study. Third parties interest in should contact the D-CARE Study staff. The IPD Data Sharing Statement is disclosed clearly to patients in our informed consent and also was approved by the responsible IRB. The data will be shared in a deidentified manner, altogether with dictionaries, glossaries, statistical/analytic codes and materials. Authors should provide a proposal that should include the merit, objectives, ethical duties and a data safety plan. For further details please contact the IPD data-sharing committee of the D-CARE Study.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: After 6 months after the release of the main report of the study up with no constraints in the upper limit.
  ipd access criteria: Under the auspicious of the IPD and steering committee of the D-CARE Study.