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/NCT05974592</url>
    </required_header>
    <id_info>
      <org_study_id>145/10</org_study_id>
      <nct_id>NCT05974592</nct_id>
    </id_info>
    <brief_title>The Effect of Nurse-Led Diabetic Foot Self-Management Training Program</brief_title>
    <official_title>The Effect of Nurse-Led Diabetic Foot Self-Management Training Program on Diabetic Foot Knowledge, Foot Care Behavior, and Self-Efficacy Levels in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hacettepe 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>
        Diabetic foot is one of the most important chronic complications of Diabetes Mellitus (DM),&#xD;
        which is a global health problem today. Diabetic foot not only affects the individual's&#xD;
        quality of life, body image, role performance, and social and economic structure of the&#xD;
        family and society but also creates a serious burden on the individual's family and health&#xD;
        system. Therefore, some approaches that include foot and nail care, shoe and sock(s)&#xD;
        selection, nutrition, and exercise practices are recommended to prevent diabetic foot and to&#xD;
        increase functional capacity, without the need for surgical treatment. It is crucial to&#xD;
        maintain these recommended approaches throughout the patient's life to ensure effective&#xD;
        management of the diabetic foot. This study aims to determine the effect of the nurse-led&#xD;
        diabetic foot self-management training program on diabetic foot knowledge, foot care&#xD;
        behavior, and self-efficacy level in patients with type 2 DM. This study was planned in a&#xD;
        randomized controlled design. The population of the study will consist of type 2 DM patients&#xD;
        who do not use insulin therapy and who applied to University of Health Sciences Diskapi&#xD;
        Yildirim Beyazit Training and Research Hospital Diabetes outpatient clinic and Diabetes&#xD;
        Education outpatient clinic between September 2022 and September 2023. According to the power&#xD;
        analysis, 38 participants are targeted to be reached in total. Data will be collected with a&#xD;
        Personal Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale,&#xD;
        Diabetic Foot Care Self-Efficacy Scale, and Diabetic Foot Evaluation Form. As a result of&#xD;
        this study, it is expected that the nurse-led diabetic foot self-management training program&#xD;
        will increase the diabetic foot knowledge, foot care behavior and self-efficacy levels of&#xD;
        diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2&#xD;
        DM.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The data to be obtained from the research will be evaluated by transferring them to the IBM&#xD;
        SPSS (Statistical Packages for the Social Sciences) Statistics 23 program. Descriptive&#xD;
        statistics for continuous variables (mean, standard deviation, median, minimum, maximum),&#xD;
        frequency distribution will be used for categorical variables. Differences between&#xD;
        categorical variables will be evaluated with Chi-square test and Fisher Exact test, and&#xD;
        relations between numerical variables will be evaluated with Spearman Correlation Analysis.&#xD;
        The conformity of the data to the normal distribution will be evaluated with the Shapiro Wilk&#xD;
        test of normality and Q-Q graphs. Accordingly, if the parametric test assumptions are met,&#xD;
        the Significance Test of the Difference Between Two Means in the comparison of independent&#xD;
        group differences; If the parametric test assumptions cannot be met, the Mann-Whitney U test&#xD;
        will be used. In dependent group comparisons, if parametric test assumptions are met,&#xD;
        Analysis of Variance in Repeated Measurements and Significance Test of Difference Between Two&#xD;
        Spouses; Friedman Test and Wilcoxon Paired Two Sample Test will be used when parametric test&#xD;
        assumptions are not met. A value of p ≤ 0.05 will be considered statistically significant in&#xD;
        all analyses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Diabetic Foot Care Self-Efficacy Scale (DABS)</measure>
      <time_frame>It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.</time_frame>
      <description>It is a Likert-type scale developed by Quarles in 2005 in accordance with western culture to determine the self-perception of diabetic patients in performing diabetic foot care activities. Self-efficacy is measured by scoring between 0 and 10. The scale consists of 9 items. The 9 statements that make up the scale are evaluated on the 11-digit visual scale, which is stated as &quot;I'm not sure = 0 and very sure = 10&quot;. The lowest score of the scale is 0, and the highest score is 90. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases. The Cronbach's alpha value of the sub-dimensions of the scale was 0.94. The validity and reliability study of the scale in the Turkish population was carried out by Kir Bicer and Enc (2014), and the Cronbach alpha value was found to be 0.86.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetic Foot Knowledge Scale (DABI)</measure>
      <time_frame>It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.</time_frame>
      <description>The Turkish validity-reliability study of the scale developed by Alexandra et al.(2001) to evaluate the diabetic foot information of diabetic patients was conducted by Biçer and Enç (2011). The scale consists of 5 items. Diabetic foot knowledge is evaluated using a 5-item DABÖ, a subscale. The Cronbach alpha value of the Turkish version of the scale was 0.58.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Care Behavior Scale (USAS)</measure>
      <time_frame>It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.</time_frame>
      <description>There are 16 items in the scale developed by Borges (2007) in line with the criteria of the American Diabetes Association (ADA) in order to improve foot care behaviors in patients with diabetes (51). The Turkish validity and reliability study was conducted by Kır Biçer and Enç (2014), and it was adapted as a 15-item Foot Care Behavior Scale in line with expert opinions. Each item in the scale is rated on a Likert-type scale between 1 (never) and 5 (always do). The lowest score that can be obtained from the scale is 15; the highest score is 75; High scores indicate that foot care behavior is sufficient. The Cronbach's alpha value for the Turkish version of the scale was found to be 0.83 (high reliability).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diabetic Foot Evaluation Form (DADF)</measure>
      <time_frame>It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.</time_frame>
      <description>Physical examination of the foot will be done by the thesis student using the Diabetic Foot Evaluation Form developed by the Diabetes Nursing Association Diabetic Foot Study Group. In this form, the fingertips, foot body and leg heat, humidity, presence of edema; nail cutting, deformity, finger examination, presence of dorsalis pedis and tibialis posterior pulses, foot sensation test, muscle strength, ankle-arm index, deformities and shoes and ulcer evaluation if any.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Diabetic Foot</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>To the participants in the intervention group; the &quot;Diabetic Foot Self-Management Training Program (DFSMTP)&quot; will be implemented. Printed, visual, and audio training materials will be used within this training program's scope. Training will be held in the Diabetes Education Room in line with the content of DFSMTP prepared by the researcher after determining the appropriate day and time with the participants. Written (training booklet) and visual (computer and PowerPoint presentation) training materials will be used during this training. The printed training booklet will be delivered to the participants at the end of the training. DFSMTP will be held in three sessions on the same day. In order to reinforce the learning of the participants in the intervention group, DFSMTP will also be video recorded with the presentation of the researcher and this recording will be transferred to the DFSMTP YouTube channel to be created by the researcher.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>To the participants in the control group; General information about the anatomy and physiology of the pancreas will be explained with the verbal lecture technique. Participants in this group will receive the training only once. Following the completion of the research, the printed training booklet and YouTube channel link information will be shared with the participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education</intervention_name>
      <description>Diabetic Foot Self-Management Training Program will be implemented.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and older&#xD;
  &#xD;
            -  Having Type 2 DM for 1 year or more,&#xD;
  &#xD;
            -  HbA1C level of 7.5% and below,&#xD;
  &#xD;
            -  Not using insulin therapy,&#xD;
  &#xD;
            -  Able to use WhatsApp himself or his relatives&#xD;
  &#xD;
            -  Individuals who volunteer to participate in the research will be included in the&#xD;
               research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or having a pregnancy plan,&#xD;
  &#xD;
            -  Mental or cognitive impairment&#xD;
  &#xD;
            -  Having a diabetic foot diagnosis confirmed by a physician,&#xD;
  &#xD;
            -  Individuals with advanced complications (retinopathy, nephropathy, peripheral arterial&#xD;
               disease, etc.) associated with DM diagnosed by a physician&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ayşe Arıkan Dönmez</last_name>
      <phone>+903123051580</phone>
      <phone_ext>149</phone_ext>
      <email>aysearikan8585@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emine Çelik Polat, PhD</last_name>
      <phone>+905315907186</phone>
      <email>celikemine995@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hacettepe University</name>
        <address>
          <city>Ankara</city>
          <zip>06100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Emine Celik Polat</investigator_full_name>
      <investigator_title>Nurse</investigator_title>
    </responsible_party>
    <keyword>diabetic foot</keyword>
    <keyword>Patient Education</keyword>
    <keyword>Foot Care</keyword>
    <keyword>Self-Efficacy</keyword>
    <keyword>Nurse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Foot</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05974592
  org study id: 145/10
  nct id: NCT05974592
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Diabetic foot is one of the most important chronic complications of Diabetes Mellitus (DM),
        which is a global health problem today. Diabetic foot not only affects the individual's
        quality of life, body image, role performance, and social and economic structure of the
        family and society but also creates a serious burden on the individual's family and health
        system. Therefore, some approaches that include foot and nail care, shoe and sock(s)
        selection, nutrition, and exercise practices are recommended to prevent diabetic foot and to
        increase functional capacity, without the need for surgical treatment. It is crucial to
        maintain these recommended approaches throughout the patient's life to ensure effective
        management of the diabetic foot. This study aims to determine the effect of the nurse-led
        diabetic foot self-management training program on diabetic foot knowledge, foot care
        behavior, and self-efficacy level in patients with type 2 DM. This study was planned in a
        randomized controlled design. The population of the study will consist of type 2 DM patients
        who do not use insulin therapy and who applied to University of Health Sciences Diskapi
        Yildirim Beyazit Training and Research Hospital Diabetes outpatient clinic and Diabetes
        Education outpatient clinic between September 2022 and September 2023. According to the power
        analysis, 38 participants are targeted to be reached in total. Data will be collected with a
        Personal Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale,
        Diabetic Foot Care Self-Efficacy Scale, and Diabetic Foot Evaluation Form. As a result of
        this study, it is expected that the nurse-led diabetic foot self-management training program
        will increase the diabetic foot knowledge, foot care behavior and self-efficacy levels of
        diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2
        DM.
  The data to be obtained from the research will be evaluated by transferring them to the IBM
        SPSS (Statistical Packages for the Social Sciences) Statistics 23 program. Descriptive
        statistics for continuous variables (mean, standard deviation, median, minimum, maximum),
        frequency distribution will be used for categorical variables. Differences between
        categorical variables will be evaluated with Chi-square test and Fisher Exact test, and
        relations between numerical variables will be evaluated with Spearman Correlation Analysis.
        The conformity of the data to the normal distribution will be evaluated with the Shapiro Wilk
        test of normality and Q-Q graphs. Accordingly, if the parametric test assumptions are met,
        the Significance Test of the Difference Between Two Means in the comparison of independent
        group differences; If the parametric test assumptions cannot be met, the Mann-Whitney U test
        will be used. In dependent group comparisons, if parametric test assumptions are met,
        Analysis of Variance in Repeated Measurements and Significance Test of Difference Between Two
        Spouses; Friedman Test and Wilcoxon Paired Two Sample Test will be used when parametric test
        assumptions are not met. A value of p ≤ 0.05 will be considered statistically significant in
        all analyses.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Investigator, Outcomes Assessor)
  measure: Diabetic Foot Care Self-Efficacy Scale (DABS)
  time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
  description: It is a Likert-type scale developed by Quarles in 2005 in accordance with western culture to determine the self-perception of diabetic patients in performing diabetic foot care activities. Self-efficacy is measured by scoring between 0 and 10. The scale consists of 9 items. The 9 statements that make up the scale are evaluated on the 11-digit visual scale, which is stated as "I'm not sure = 0 and very sure = 10". The lowest score of the scale is 0, and the highest score is 90. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases. The Cronbach's alpha value of the sub-dimensions of the scale was 0.94. The validity and reliability study of the scale in the Turkish population was carried out by Kir Bicer and Enc (2014), and the Cronbach alpha value was found to be 0.86.
  measure: Diabetic Foot Knowledge Scale (DABI)
  time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
  description: The Turkish validity-reliability study of the scale developed by Alexandra et al.(2001) to evaluate the diabetic foot information of diabetic patients was conducted by Biçer and Enç (2011). The scale consists of 5 items. Diabetic foot knowledge is evaluated using a 5-item DABÖ, a subscale. The Cronbach alpha value of the Turkish version of the scale was 0.58.
  measure: Foot Care Behavior Scale (USAS)
  time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
  description: There are 16 items in the scale developed by Borges (2007) in line with the criteria of the American Diabetes Association (ADA) in order to improve foot care behaviors in patients with diabetes (51). The Turkish validity and reliability study was conducted by Kır Biçer and Enç (2014), and it was adapted as a 15-item Foot Care Behavior Scale in line with expert opinions. Each item in the scale is rated on a Likert-type scale between 1 (never) and 5 (always do). The lowest score that can be obtained from the scale is 15; the highest score is 75; High scores indicate that foot care behavior is sufficient. The Cronbach's alpha value for the Turkish version of the scale was found to be 0.83 (high reliability).
  measure: Diabetic Foot Evaluation Form (DADF)
  time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
  description: Physical examination of the foot will be done by the thesis student using the Diabetic Foot Evaluation Form developed by the Diabetes Nursing Association Diabetic Foot Study Group. In this form, the fingertips, foot body and leg heat, humidity, presence of edema; nail cutting, deformity, finger examination, presence of dorsalis pedis and tibialis posterior pulses, foot sensation test, muscle strength, ankle-arm index, deformities and shoes and ulcer evaluation if any.
  arm group label: Intervention Group
  arm group type: Experimental
  description: To the participants in the intervention group; the "Diabetic Foot Self-Management Training Program (DFSMTP)" will be implemented. Printed, visual, and audio training materials will be used within this training program's scope. Training will be held in the Diabetes Education Room in line with the content of DFSMTP prepared by the researcher after determining the appropriate day and time with the participants. Written (training booklet) and visual (computer and PowerPoint presentation) training materials will be used during this training. The printed training booklet will be delivered to the participants at the end of the training. DFSMTP will be held in three sessions on the same day. In order to reinforce the learning of the participants in the intervention group, DFSMTP will also be video recorded with the presentation of the researcher and this recording will be transferred to the DFSMTP YouTube channel to be created by the researcher.
  arm group label: Control Group
  arm group type: No Intervention
  description: To the participants in the control group; General information about the anatomy and physiology of the pancreas will be explained with the verbal lecture technique. Participants in this group will receive the training only once. Following the completion of the research, the printed training booklet and YouTube channel link information will be shared with the participants.
  intervention type: Other
  intervention name: Education
  description: Diabetic Foot Self-Management Training Program will be implemented.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ayşe Arıkan Dönmez
  phone: +903123051580
  phone ext: 149
  email: aysearikan8585@gmail.com
  last name: Emine Çelik Polat, PhD
  phone: +905315907186
  email: celikemine995@gmail.com
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Emine Celik Polat
  investigator title: Nurse
  mesh term: Diabetic Foot
  sharing ipd: No