<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/NCT02974413</url>
  </required_header>
  <id_info>
    <org_study_id>State University of Maringá</org_study_id>
    <nct_id>NCT02974413</nct_id>
  </id_info>
  <brief_title>Effectiveness of Self-care Rests on Knowledge, Self-care and Cardiometabolic Control of Adult Men With Diabetes Mellitus</brief_title>
  <official_title>Effectiveness of Self-care Rests on Knowledge, Self-care and Cardiometabolic Control of Adult Men With Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual de Maringá</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual de Maringá</source>
  <brief_summary>
    <textblock>
      This research project has the main objective to analyze the benefits of self-care supported&#xD;
      for adult men with Diabetes Mellitus. Treat yourself will randomized-controlled clinical&#xD;
      study, randomized cluster to be developed with men aged between 40 and 70 years who have type&#xD;
      2 diabetes and are registered with the Health Strategy teams of the Municipality of Family&#xD;
      Maringa. The recruited subjects will be randomly allocated into two groups: intervention&#xD;
      group and control group. In the first, individuals will participate in a self-care&#xD;
      intervention supported by a nurse, based on supported self-care and behavior change protocol;&#xD;
      and second, individuals participate in conversation circles and will have the assistance&#xD;
      normally provided by health services. The follow-up will take place for six months and will&#xD;
      be collected information: socioeconomic, demographic, behavioral health, complications,&#xD;
      laboratory and anthropometric. It is intended, through this study, demonstrate the&#xD;
      effectiveness of this type of intervention, user-centric, on the health of men with DM,&#xD;
      reinforcing this option of choice for professionals and users within the Primary Health Care&#xD;
      (PHC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <primary_completion_date type="Actual">November 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Change in glycemic control between baseline and six months: should be determined by the values of glycated hemoglobin, which will be compared between the two moments (baseline and six months).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-care attitudes</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Self-care attitudes: measured from QAD questionnaire ( Self Care Questionnaire in Diabetes). For the analysis of adherence to the questionnaire items, they will be parameterized in number of days per week, from zero to seven, zero being the least desirable and seven to more favorable situation, with the exception of items the size specific power that question assessing the consumption of foods rich in fat and sweets, for which the values are reversed, Ie in relation to these foods, the higher the score, or the number of days, the less desirable it is. It will be evaluated by the average number of days. comparisons will be made between the beginning and at the end of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy (or Empowerment)</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Self-efficacy (or Empowerment): measured from the self-efficacy scale in diabetes - short version (EAD -VC). The questionnaire addresses the training for the care of diabetes. Eight statements for which the respondent demonstrate their level of agreement, using a Likert scale of five points that part of &quot;strongly disagree&quot; (one point ) to&quot; strongly agree&quot; (five points). The overall score is calculated by the average of the scores of each of the eight items. It is considered high a score of 3.8-5.0, an average of 2.4-3.7 and low at 1-2.3. comparisons will be made between the beginning and at the end of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological adjustment</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Psychological adjustment: We used the ATT -19 instrument, which contains 19 items and describes the emotional responses of the DM. Each statement is answered with the help of a kind of scale Likert five points, from &quot; Strongly disagree&quot; to&quot; Strongly agree&quot;. TTA -19 Apontuação will 19-95 points. To achieve a positive attitude about DM, the user needs to achieve a minimum score of 70 points. comparisons will be made between the beginning and at the end of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge about diabetes</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Knowledge about diabetes: test was used which has a total score of 15 points, addressing the knowledge of the DM. The DKN-A is associated with psychological, hypoglycemia, insulin, food groups, replacement of food, DM management and general principles of care of the disease. To show a satisfactory knowledge of the DM, the user needs to do at least 8 points. comparisons will be made between the beginning and at the end of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical indicators of cardiometabolic control</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Clinical indicators of cardiometabolic control (Blood Pressure, Body Fat Percentage, CA, WHR, BMI, weight, fasting glucose, triglycerides, total cholesterol, HDL, LDL, Creatinine Plasma). comparisons will be made between the beginning and at the end of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Height in meters (m), measured by portable stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline and six months</time_frame>
    <description>Weight in kilograms (kg), measured by means of a portable scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention to be performed will be based on the principles and steps of supported self-care, guided by Behavior Change Protocol (Behavior Change Protocol - BCP) and consists of an educational program with quarterly meetings, and individual at home, through home visits, and group in the Basic Health Unit (BHU), in addition to telephone monitoring in the interval between two meetings. This intervention will be applied together adult men with type 2 diabetes who are randomized in the intervention group (IG) for six months. Thus, these men will take part in three meetings, individual or group, and will receive four telephone calls in between the face meetings. Our objective is to draw with this intervention by the participant, an individual plan of self-care, based on concretras goals and supports you in the implementation of this plan, in order to improve their self-efficacy in self-care and therefore glycemic control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The study will also include a Control Group (CG), and the participants of this group will participate in conversation circles at the beginning and the end of the six month follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self-care supported</intervention_name>
    <description>The intervention to be performed will be based on the principles and steps of supported self-care, guided by Behavior Change Protocol (Behavior Change Protocol - BCP) and consists of an educational program with quarterly meetings, and individual at home, through home visits, and group in the Basic Health Unit (BHU), in addition to telephone monitoring in the interval between two meetings. This intervention will be applied together adult men with type 2 diabetes who are randomized in the intervention group (IG) for six months. Thus, these men will take part in three meetings, individual or group, and will receive four telephone calls in between the face meetings. Our objective is to draw with this intervention by the participant, an individual plan of self-care, based on concretras goals and supports you in the implementation of this plan, in order to improve their self-efficacy in self-care and therefore glycemic control.The study will also include a Control Group (CG).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having medical diagnosis of DM2;&#xD;
&#xD;
          -  Being male;&#xD;
&#xD;
          -  Age between 20 and 59 years;&#xD;
&#xD;
          -  Is domiciled in the city of Maringa in the FHS coverage area; Being part of the ESF&#xD;
             families register.&#xD;
&#xD;
          -  Being able to answer the questions of data collection instruments;&#xD;
&#xD;
          -  Relate visual ability , hearing and locomotor to perform self-care;&#xD;
&#xD;
          -  Have telephone contact (mobile or fixed) for monitoring the program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Present lesions in target organs (brain, heart, kidneys, eyes) or&#xD;
             comorbidities/complications resulting from diabetes, recorded in medical records, such&#xD;
             as chronic renal failure;&#xD;
&#xD;
          -  Have psychological or other disorders , registered in the medical records, and that&#xD;
             compromise the understanding of the study, who do not agree or do not have&#xD;
             availability to participate in the intervention;&#xD;
&#xD;
          -  Moving to another location that does not have coverage of the ESF, or even to another&#xD;
             city.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Guilherme Arruda, Master</last_name>
    <phone>4491663381</phone>
    <email>enfgoa@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidade Estadual de Maringá</name>
      <address>
        <city>Maringá</city>
        <state>Paraná</state>
        <zip>87020-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guilherme O Arruda, Master</last_name>
      <phone>4491663381</phone>
      <email>enfgoa@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual de Maringá</investigator_affiliation>
    <investigator_full_name>Guilherme Oliveira de Arruda</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02974413
org study id: State University of Maringá
nct id: NCT02974413
lead sponsor: 
This research project has the main objective to analyze the benefits of self-care supported
      for adult men with Diabetes Mellitus. Treat yourself will randomized-controlled clinical
      study, randomized cluster to be developed with men aged between 40 and 70 years who have type
      2 diabetes and are registered with the Health Strategy teams of the Municipality of Family
      Maringa. The recruited subjects will be randomly allocated into two groups: intervention
      group and control group. In the first, individuals will participate in a self-care
      intervention supported by a nurse, based on supported self-care and behavior change protocol;
      and second, individuals participate in conversation circles and will have the assistance
      normally provided by health services. The follow-up will take place for six months and will
      be collected information: socioeconomic, demographic, behavioral health, complications,
      laboratory and anthropometric. It is intended, through this study, demonstrate the
      effectiveness of this type of intervention, user-centric, on the health of men with DM,
      reinforcing this option of choice for professionals and users within the Primary Health Care
      (PHC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glycemic control
time frame: Baseline and six months
description: Change in glycemic control between baseline and six months: should be determined by the values of glycated hemoglobin, which will be compared between the two moments (baseline and six months).
measure: Self-care attitudes
time frame: Baseline and six months
description: Self-care attitudes: measured from QAD questionnaire ( Self Care Questionnaire in Diabetes). For the analysis of adherence to the questionnaire items, they will be parameterized in number of days per week, from zero to seven, zero being the least desirable and seven to more favorable situation, with the exception of items the size specific power that question assessing the consumption of foods rich in fat and sweets, for which the values are reversed, Ie in relation to these foods, the higher the score, or the number of days, the less desirable it is. It will be evaluated by the average number of days. comparisons will be made between the beginning and at the end of the intervention.
measure: Self-efficacy (or Empowerment)
time frame: Baseline and six months
description: Self-efficacy (or Empowerment): measured from the self-efficacy scale in diabetes - short version (EAD -VC). The questionnaire addresses the training for the care of diabetes. Eight statements for which the respondent demonstrate their level of agreement, using a Likert scale of five points that part of "strongly disagree" (one point ) to" strongly agree" (five points). The overall score is calculated by the average of the scores of each of the eight items. It is considered high a score of 3.8-5.0, an average of 2.4-3.7 and low at 1-2.3. comparisons will be made between the beginning and at the end of the intervention.
measure: Psychological adjustment
time frame: Baseline and six months
description: Psychological adjustment: We used the ATT -19 instrument, which contains 19 items and describes the emotional responses of the DM. Each statement is answered with the help of a kind of scale Likert five points, from " Strongly disagree" to" Strongly agree". TTA -19 Apontuação will 19-95 points. To achieve a positive attitude about DM, the user needs to achieve a minimum score of 70 points. comparisons will be made between the beginning and at the end of the intervention.
measure: Knowledge about diabetes
time frame: Baseline and six months
description: Knowledge about diabetes: test was used which has a total score of 15 points, addressing the knowledge of the DM. The DKN-A is associated with psychological, hypoglycemia, insulin, food groups, replacement of food, DM management and general principles of care of the disease. To show a satisfactory knowledge of the DM, the user needs to do at least 8 points. comparisons will be made between the beginning and at the end of the intervention.
measure: Clinical indicators of cardiometabolic control
time frame: Baseline and six months
description: Clinical indicators of cardiometabolic control (Blood Pressure, Body Fat Percentage, CA, WHR, BMI, weight, fasting glucose, triglycerides, total cholesterol, HDL, LDL, Creatinine Plasma). comparisons will be made between the beginning and at the end of the intervention.
measure: Height
time frame: Baseline and six months
description: Height in meters (m), measured by portable stadiometer.
measure: Weight
time frame: Baseline and six months
description: Weight in kilograms (kg), measured by means of a portable scale.
arm group label: Intervention
arm group type: Experimental
description: The intervention to be performed will be based on the principles and steps of supported self-care, guided by Behavior Change Protocol (Behavior Change Protocol - BCP) and consists of an educational program with quarterly meetings, and individual at home, through home visits, and group in the Basic Health Unit (BHU), in addition to telephone monitoring in the interval between two meetings. This intervention will be applied together adult men with type 2 diabetes who are randomized in the intervention group (IG) for six months. Thus, these men will take part in three meetings, individual or group, and will receive four telephone calls in between the face meetings. Our objective is to draw with this intervention by the participant, an individual plan of self-care, based on concretras goals and supports you in the implementation of this plan, in order to improve their self-efficacy in self-care and therefore glycemic control.
arm group label: Control
arm group type: No Intervention
description: The study will also include a Control Group (CG), and the participants of this group will participate in conversation circles at the beginning and the end of the six month follow-up.
intervention type: Behavioral
intervention name: self-care supported
description: The intervention to be performed will be based on the principles and steps of supported self-care, guided by Behavior Change Protocol (Behavior Change Protocol - BCP) and consists of an educational program with quarterly meetings, and individual at home, through home visits, and group in the Basic Health Unit (BHU), in addition to telephone monitoring in the interval between two meetings. This intervention will be applied together adult men with type 2 diabetes who are randomized in the intervention group (IG) for six months. Thus, these men will take part in three meetings, individual or group, and will receive four telephone calls in between the face meetings. Our objective is to draw with this intervention by the participant, an individual plan of self-care, based on concretras goals and supports you in the implementation of this plan, in order to improve their self-efficacy in self-care and therefore glycemic control.The study will also include a Control Group (CG).
arm group label: Intervention
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Guilherme Arruda, Master
phone: 4491663381
email: enfgoa@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual de Maringá
investigator full name: Guilherme Oliveira de Arruda
investigator title: PhD Student
mesh term: Diabetes Mellitus