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/NCT05983120</url>
    </required_header>
    <id_info>
      <org_study_id>Afyonkarahisar HSU</org_study_id>
      <nct_id>NCT05983120</nct_id>
    </id_info>
    <brief_title>Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus</brief_title>
    <official_title>The Effect of Education Provided According to Social Cognitive Learning Theory on Diabetes Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Afyonkarahisar Health Sciences University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Afyonkarahisar Health Sciences University</source>
    <oversight_info>
      <has_dmc>No</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>
        The study was conducted in order to study the effect of the training given according to&#xD;
        social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life&#xD;
        among type 2 diabetes mellitus individuals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was done as a randomized-controlled experimental study at Internal Diseases&#xD;
        Polyclinics of Afyonkarahisar Public Hospital between November 2021 and August 2022. The&#xD;
        study was completed with 60 patients -experimental group (30 patients) and control group (30&#xD;
        patients)- who met inclusion criteria. The data were gathered using Information Request Form&#xD;
        and Metabolic Variables Form, Diabetes Self-Management Scale (DSMS) for Type 2 Diabetic&#xD;
        Patients, Multidimensional Scale of Perceived Social Support (MSPSS), Type 2 Diabetes&#xD;
        Mellitus Self-Management Questionnaire (SMQ), WHOQOL-BREF (WHO- Quality of Life Scale- Short&#xD;
        form). A theoretical and practical training based on SCLT was provided to the experimental&#xD;
        group for the first five weeks -one module for each week- through power point presentations&#xD;
        and afterwards, SMS reminders were sent every fifteen days for seven weeks and at the end of&#xD;
        the twelfth week the training was completed. The control group received a standard training&#xD;
        from diabetes nurse. The data were assessed using statistical methods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 19, 2021</start_date>
    <completion_date type="Actual">January 3, 2023</completion_date>
    <primary_completion_date type="Actual">August 20, 2022</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>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determining the principle of mutual determination from the principles of the social cognitive learning theory (SCLT)</measure>
      <time_frame>twelve weeks</time_frame>
      <description>It was evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS). The lowest score that can be obtained from the entire scale is 12, and the highest score is 84. A high score indicates high perceived social support.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determination of self-regulation capacity from the principles of SCLT.</measure>
      <time_frame>twelve weeks</time_frame>
      <description>There is no specific score range.High scores on the scale indicate good self-management (SMQ), and low scores indicate poor self-management.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determination of self-judgment capacity, one of the principles of SCLT.</measure>
      <time_frame>twelve weeks</time_frame>
      <description>DM was assessed with the Self-Efficacy Scale (DSMS). The lowest score that can be obtained from the scale is 20, and the highest score is 100. In the sample, the scale score average is calculated and individuals who are above the average are evaluated as high self-efficacy, and individuals below the average are evaluated as low self-efficacy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determining the effect of SCLT-based education on Quality of Life</measure>
      <time_frame>twelve weeks</time_frame>
      <description>Evaluated by WHOQOL - BREF (World Health Organization Quality of Life Scale - Short Form). It has four sub-dimensions: physical health such as pain, sleep, energy, psychological health such as positive emotions, self-confidence, body image, social relations such as social support, personal relations and environmental health such as economic status, transportation, safe environment and health conditions. A high score indicates a high quality of life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determination of blood HbA1c value.</measure>
      <time_frame>twelve weeks</time_frame>
      <description>HbA1c (glycosylated hemoglobin). Indicates the average blood glucose value over the last 2 to 3 months. The HbA1c reference range should be 5.7-6.4%. HbA1c level ≥6.5% or ≤5.6 poor glycemic control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of Fasting Blood Glucose (FLA) value.</measure>
      <time_frame>twelve weeks</time_frame>
      <description>It is the glucose value (plasma glucose) measured from a blood sample taken after eight or twelve hours of fasting. The normal reference range is min 80 mg/dl - max 130 mg/dl. FLA level ≥130 mg/dl or ≤80 mg/dl poor glycemic control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of blood Postprandial Blood Glucose (TKS) value.</measure>
      <time_frame>twelve weeks</time_frame>
      <description>TCS is the plasma glucose value measured two hours after the start of food intake after an eight-hour fast. The reference range is 140-199 mg/dl. TKS ≥200 mg/dl or ≤139 mg/dl a weak glycemic control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values.</measure>
      <time_frame>twelve weeks</time_frame>
      <description>A blood sample taken after eight or twelve hours of fasting is used to determine the fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values. Fasting lipid profile reference range is (Total cholesterol 20 - 200 mg/dl, High Density Lipoprotein (HDL) reference range is 35 - 65 mg/dl, Low Density Lipoprotein (LDL) reference range is 60 - 130 mg/dl, Triglyceride reference range is 20 - 203 mg/dl). Values less or higher than the specified values are considered as negative cholesterol levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of Body Mass Index (BMI)</measure>
      <time_frame>twelve weeks</time_frame>
      <description>BMI is calculated by dividing body weight (kg) by height (m) squared (kg/m²). Results below 18.5 kg/m²: Below ideal weight Results between 18.5 kg/m² and 24.9 kg/m²: At ideal weight Results from 25 kg/m² to 29.9 kg/m²: Above ideal weight Results between 30 kg/m² and 39.9 kg/m²: Well above ideal weight (obese) Results over 40 kg/m²: It is considered as well above the ideal weight (morbidly obese).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Pre-Existing Type 2 Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the first five weeks, the experimental group was given training consisting of five modules, accompanied by power point presentations and applied social cognitive learning theory, then SMS reminders were sent every fortnight for seven weeks, and the study was completed at the end of the twelfth week. The control group received standard training from a diabetes nurse. Scale evaluations, metabolic and anthropometric measurements were made at the beginning and end of the study in the experimental and control groups. In addition, the scale evaluation was repeated in the fifth week for the experimental group. Data were evaluated using appropriate statistical methods.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group received standard training from a diabetes nurse.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education</intervention_name>
      <description>Educate the patients who suffer from Type 2 Diabetes Mellitus</description>
      <arm_group_label>Training group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and over&#xD;
  &#xD;
            -  Being diagnosed with Type 2 diabetes mellitus,&#xD;
  &#xD;
            -  Being on insulin therapy,&#xD;
  &#xD;
            -  Being open to verbal communication,&#xD;
  &#xD;
            -  Being literate&#xD;
  &#xD;
            -  Not to have an obstacle to continue the implementation phase of the research (for&#xD;
               example, pregnancy plan, changing province, etc.)&#xD;
  &#xD;
            -  Not having hearing-vision problems and diabetes-related serious neuropathy&#xD;
               (amputation, etc.),&#xD;
  &#xD;
            -  Patients who agreed to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:The patient has a perception disorder and psychiatric disorder that&#xD;
          prevents communication,&#xD;
  &#xD;
            -  Being pregnant,&#xD;
  &#xD;
            -  Individuals with serious complications such as retinopathy and neuropathy at the level&#xD;
               of blindness were excluded from the study.&#xD;
  &#xD;
          Research Termination Criteria&#xD;
  &#xD;
            -  Not performing the specified applications properly during the study,&#xD;
  &#xD;
            -  Unreachable in follow-ups,&#xD;
  &#xD;
            -  Those who want to quit working,&#xD;
  &#xD;
            -  Serious complications related to comorbid diseases and diabetes that occur during the&#xD;
               working process,&#xD;
  &#xD;
            -  The study was terminated with patients who were moved out of the province during the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yasemin Celik</last_name>
      <role>Principal Investigator</role>
      <affiliation>Afyonkarahisar Health Sciences University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sibel Karaca Sivrikaya</last_name>
      <role>Study Director</role>
      <affiliation>Balikesir University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alper Emre Kurt</last_name>
      <role>Study Chair</role>
      <affiliation>Afyonkarahisar goverment hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sezen Yılmaz</last_name>
      <role>Study Chair</role>
      <affiliation>Afyonkarahisar goverment hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Afyonkarahisar Health Sciences University</name>
        <address>
          <city>Afyonkarahisar</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>January 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Afyonkarahisar Health Sciences University</investigator_affiliation>
      <investigator_full_name>Yasemin Çelik</investigator_full_name>
      <investigator_title>Dr. assistant professor</investigator_title>
    </responsible_party>
    <keyword>Type 2 Diabetes</keyword>
    <keyword>Social Cognitive Learning</keyword>
    <keyword>Diabetes Self-management</keyword>
    <keyword>Quality of Life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>December 3, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT05983120/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05983120
  org study id: Afyonkarahisar HSU
  nct id: NCT05983120
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study was conducted in order to study the effect of the training given according to
        social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life
        among type 2 diabetes mellitus individuals.
  The study was done as a randomized-controlled experimental study at Internal Diseases
        Polyclinics of Afyonkarahisar Public Hospital between November 2021 and August 2022. The
        study was completed with 60 patients -experimental group (30 patients) and control group (30
        patients)- who met inclusion criteria. The data were gathered using Information Request Form
        and Metabolic Variables Form, Diabetes Self-Management Scale (DSMS) for Type 2 Diabetic
        Patients, Multidimensional Scale of Perceived Social Support (MSPSS), Type 2 Diabetes
        Mellitus Self-Management Questionnaire (SMQ), WHOQOL-BREF (WHO- Quality of Life Scale- Short
        form). A theoretical and practical training based on SCLT was provided to the experimental
        group for the first five weeks -one module for each week- through power point presentations
        and afterwards, SMS reminders were sent every fifteen days for seven weeks and at the end of
        the twelfth week the training was completed. The control group received a standard training
        from diabetes nurse. The data were assessed using statistical methods.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Determining the principle of mutual determination from the principles of the social cognitive learning theory (SCLT)
  time frame: twelve weeks
  description: It was evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS). The lowest score that can be obtained from the entire scale is 12, and the highest score is 84. A high score indicates high perceived social support.
  measure: Determination of self-regulation capacity from the principles of SCLT.
  time frame: twelve weeks
  description: There is no specific score range.High scores on the scale indicate good self-management (SMQ), and low scores indicate poor self-management.
  measure: Determination of self-judgment capacity, one of the principles of SCLT.
  time frame: twelve weeks
  description: DM was assessed with the Self-Efficacy Scale (DSMS). The lowest score that can be obtained from the scale is 20, and the highest score is 100. In the sample, the scale score average is calculated and individuals who are above the average are evaluated as high self-efficacy, and individuals below the average are evaluated as low self-efficacy.
  measure: Determining the effect of SCLT-based education on Quality of Life
  time frame: twelve weeks
  description: Evaluated by WHOQOL - BREF (World Health Organization Quality of Life Scale - Short Form). It has four sub-dimensions: physical health such as pain, sleep, energy, psychological health such as positive emotions, self-confidence, body image, social relations such as social support, personal relations and environmental health such as economic status, transportation, safe environment and health conditions. A high score indicates a high quality of life.
  measure: Determination of blood HbA1c value.
  time frame: twelve weeks
  description: HbA1c (glycosylated hemoglobin). Indicates the average blood glucose value over the last 2 to 3 months. The HbA1c reference range should be 5.7-6.4%. HbA1c level ≥6.5% or ≤5.6 poor glycemic control.
  measure: Determination of Fasting Blood Glucose (FLA) value.
  time frame: twelve weeks
  description: It is the glucose value (plasma glucose) measured from a blood sample taken after eight or twelve hours of fasting. The normal reference range is min 80 mg/dl - max 130 mg/dl. FLA level ≥130 mg/dl or ≤80 mg/dl poor glycemic control.
  measure: Determination of blood Postprandial Blood Glucose (TKS) value.
  time frame: twelve weeks
  description: TCS is the plasma glucose value measured two hours after the start of food intake after an eight-hour fast. The reference range is 140-199 mg/dl. TKS ≥200 mg/dl or ≤139 mg/dl a weak glycemic control.
  measure: Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values.
  time frame: twelve weeks
  description: A blood sample taken after eight or twelve hours of fasting is used to determine the fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values. Fasting lipid profile reference range is (Total cholesterol 20 - 200 mg/dl, High Density Lipoprotein (HDL) reference range is 35 - 65 mg/dl, Low Density Lipoprotein (LDL) reference range is 60 - 130 mg/dl, Triglyceride reference range is 20 - 203 mg/dl). Values less or higher than the specified values are considered as negative cholesterol levels.
  measure: Determination of Body Mass Index (BMI)
  time frame: twelve weeks
  description: BMI is calculated by dividing body weight (kg) by height (m) squared (kg/m²). Results below 18.5 kg/m²: Below ideal weight Results between 18.5 kg/m² and 24.9 kg/m²: At ideal weight Results from 25 kg/m² to 29.9 kg/m²: Above ideal weight Results between 30 kg/m² and 39.9 kg/m²: Well above ideal weight (obese) Results over 40 kg/m²: It is considered as well above the ideal weight (morbidly obese).
  arm group label: Training group
  arm group type: Experimental
  description: In the first five weeks, the experimental group was given training consisting of five modules, accompanied by power point presentations and applied social cognitive learning theory, then SMS reminders were sent every fortnight for seven weeks, and the study was completed at the end of the twelfth week. The control group received standard training from a diabetes nurse. Scale evaluations, metabolic and anthropometric measurements were made at the beginning and end of the study in the experimental and control groups. In addition, the scale evaluation was repeated in the fifth week for the experimental group. Data were evaluated using appropriate statistical methods.
  arm group label: Control Group
  arm group type: No Intervention
  description: The control group received standard training from a diabetes nurse.
  intervention type: Other
  intervention name: Education
  description: Educate the patients who suffer from Type 2 Diabetes Mellitus
  arm group label: Training group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yasemin Celik
  role: Principal Investigator
  affiliation: Afyonkarahisar Health Sciences University
  last name: Sibel Karaca Sivrikaya
  role: Study Director
  affiliation: Balikesir University
  last name: Alper Emre Kurt
  role: Study Chair
  affiliation: Afyonkarahisar goverment hospital
  last name: Sezen Yılmaz
  role: Study Chair
  affiliation: Afyonkarahisar goverment hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Afyonkarahisar Health Sciences University
  investigator full name: Yasemin Çelik
  investigator title: Dr. assistant professor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No
  provided document: 