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/NCT05962268</url>
    </required_header>
    <id_info>
      <org_study_id>E-64577500-050.99-30751</org_study_id>
      <nct_id>NCT05962268</nct_id>
    </id_info>
    <brief_title>The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs</brief_title>
    <official_title>The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs Patıents' Self-Care Behavıors: A Randomızed Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Izmir Bakircay University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Izmir Bakircay 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>
        Objective: This study aimed to determine the effect of face-to-face and video-based education&#xD;
        for fistula care on hemodialysis patients' self-care behaviors.&#xD;
  &#xD;
        Methods: The study was conducted as a randomized controlled experimental study. Fistula care&#xD;
        training was given to the patients in the control group using face-to-face education&#xD;
        technique. Fistula care training was given to the patients in the experimental group using a&#xD;
        video based technique.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Experimental group: The researcher provided the patient education the on fistula care. In&#xD;
        this training, the researcher first verbally explained fistula care to the patients. After&#xD;
        the verbal training, a video recording about fistula care was shown to the patients. The&#xD;
        patients watched the video recording during dialysis using the TV unit at the bedside. The&#xD;
        training took 20 minutes. Patients were allowed to watch the training video twice, at a&#xD;
        one-week interval, when they came for hemodialysis treatment after the condition of the&#xD;
        patients on dialysis stabilized.&#xD;
  &#xD;
        Topics: Video recordings on of fistula care was done by the researchers in the vocational&#xD;
        skills laboratory. The video flow plan included the introduction of the materials to be used&#xD;
        in fistula care as well as the researcher's presentation of how to manage the fistula.&#xD;
        Fistula care steps were performed on the simulation model. In addition, the precautions to be&#xD;
        taken during the application and what to do in case of possible complications were also&#xD;
        shown.&#xD;
  &#xD;
        Literature review, research results, clinicians' opinions, and experts and practices were&#xD;
        used in editing the content of verbal training and video recording,&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Actual">December 30, 2022</completion_date>
    <primary_completion_date type="Actual">December 15, 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>Supportive Care</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Information Form</measure>
      <time_frame>10 minutes</time_frame>
      <description>The form consists of 12 items related to patients' gender, age, marital status, educational status, occupation, income status, duration of chronic renal failure (CRF), duration of hemodialysis, number of weekly hemodialysis, first AVF cannulation, number of AVFs, previous AVF care, and status or receiving education on kidney failure. It consists of 12 questions that determine the educational status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF)</measure>
      <time_frame>10 minutes</time_frame>
      <description>The scale developed by Sousa et al. (2015) can be used for the education and follow-up of patients, in addition to evaluating the care behaviors of patients towards their AVF. Each item is scored according to the its reverse statement. On the scale, a score of 1 indicates that the specified self-care behavior has never developed, and a score of 5 indicates that the specified self-care behavior is always present. The scale is concluded by summing the scores from each statement. The minimum score that can be obtained from the scale is 16, and the maximum score is 80. As the score increases, the self-care behaviors of the person improve. The validity and reliability of the scale for the Turkish population were determined by İkiz and Yıldırım Usta (2016), and the Cronbach alpha coefficient of the scale was reported to be 0.91.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Hemolysis</condition>
    <arm_group>
      <arm_group_label>Video based education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The video was prepared by the researchers in line with the literature. Expert opinion was obtained from 10 individuals with at least a doctorate and studies on the subject of video content. In line with expert opinions, the video content was updated and finalized. Patient education with the prepared video was provided by one of the researchers involved in the study. The video education took 20 minutes in total.&#xD;
  Topics: Video recordings on of fistula care was done by the researchers in the vocational skills laboratory. The video flow plan included the introduction of the materials to be used in fistula care as well as the researcher's presentation of how to manage the fistula. Fistula care steps were performed on the simulation model. In addition, the precautions to be taken during the application and what to do in case of possible complications were also shown.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Face to face education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients were trained on fistula care by the researcher. Fistula care training was given to the patients in the control group using face-to-face education technique. In this training, researcher verbally explained fistula care to patients. The training was conducted one-on-one with the patient in the patient's room and lasted 10 minutes. The training was presented to the patient through the lecture method. The training was also supported by the question-and-answer method. The training was given twice, one week apart, when patients came for hemodialysis treatment after the condition of the patients on dialysis stabilized.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Video based education</intervention_name>
      <description>The video was prepared by the researchers in line with the literature. Expert opinion was obtained from 10 individuals with at least a doctorate and studies on the subject of video content. In line with expert opinions, the video content was updated and finalized. Patient education with the prepared video was provided by one of the researchers involved in the study. The video education took 20 minutes in total.</description>
      <arm_group_label>Video based education</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Face to face education</intervention_name>
      <description>The patients were trained on fistula care by the researcher. Fistula care training was given to the patients in the control group using face-to-face education technique. In this training, researcher verbally explained fistula care to patients. The training was conducted one-on-one with the patient in the patient's room and lasted 10 minutes. The training was presented to the patient through the lecture method. The training was also supported by the question-and-answer method. The training was given twice, one week apart, when patients came for hemodialysis treatment after the condition of the patients on dialysis stabilized.</description>
      <arm_group_label>Face to face education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being 18 years or older,&#xD;
  &#xD;
            -  Receiving hemodialysis treatment for more than 6 months,&#xD;
  &#xD;
            -  Having arteriovenous fistula,&#xD;
  &#xD;
            -  Being able to read, understand and speak Turkish,&#xD;
  &#xD;
            -  Not having any physical, mental or mental disability restricting daily activities,&#xD;
  &#xD;
            -  Having no visual-hearing impairment, perception and psychiatric problems,&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not having arteriovenous fistula,&#xD;
  &#xD;
            -  Declining to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Kayseri Dialysis Center</name>
        <address>
          <city>Kayseri</city>
          <state>Talas</state>
          <zip>38000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Izmir Bakircay University</investigator_affiliation>
      <investigator_full_name>seda şahan</investigator_full_name>
      <investigator_title>Izmir Bakircay University</investigator_title>
    </responsible_party>
    <keyword>fistula care</keyword>
    <keyword>education</keyword>
    <keyword>self care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fistula</mesh_term>
      <mesh_term>Hemolysis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Information can be obtained from the principal investigator via e-mail.</ipd_description>
    </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/NCT05962268
  org study id: E-64577500-050.99-30751
  nct id: NCT05962268
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective: This study aimed to determine the effect of face-to-face and video-based education
        for fistula care on hemodialysis patients' self-care behaviors.
  
        Methods: The study was conducted as a randomized controlled experimental study. Fistula care
        training was given to the patients in the control group using face-to-face education
        technique. Fistula care training was given to the patients in the experimental group using a
        video based technique.
  Experimental group: The researcher provided the patient education the on fistula care. In
        this training, the researcher first verbally explained fistula care to the patients. After
        the verbal training, a video recording about fistula care was shown to the patients. The
        patients watched the video recording during dialysis using the TV unit at the bedside. The
        training took 20 minutes. Patients were allowed to watch the training video twice, at a
        one-week interval, when they came for hemodialysis treatment after the condition of the
        patients on dialysis stabilized.
  
        Topics: Video recordings on of fistula care was done by the researchers in the vocational
        skills laboratory. The video flow plan included the introduction of the materials to be used
        in fistula care as well as the researcher's presentation of how to manage the fistula.
        Fistula care steps were performed on the simulation model. In addition, the precautions to be
        taken during the application and what to do in case of possible complications were also
        shown.
  
        Literature review, research results, clinicians' opinions, and experts and practices were
        used in editing the content of verbal training and video recording,
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Investigator)
  measure: Patient Information Form
  time frame: 10 minutes
  description: The form consists of 12 items related to patients' gender, age, marital status, educational status, occupation, income status, duration of chronic renal failure (CRF), duration of hemodialysis, number of weekly hemodialysis, first AVF cannulation, number of AVFs, previous AVF care, and status or receiving education on kidney failure. It consists of 12 questions that determine the educational status.
  measure: Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF)
  time frame: 10 minutes
  description: The scale developed by Sousa et al. (2015) can be used for the education and follow-up of patients, in addition to evaluating the care behaviors of patients towards their AVF. Each item is scored according to the its reverse statement. On the scale, a score of 1 indicates that the specified self-care behavior has never developed, and a score of 5 indicates that the specified self-care behavior is always present. The scale is concluded by summing the scores from each statement. The minimum score that can be obtained from the scale is 16, and the maximum score is 80. As the score increases, the self-care behaviors of the person improve. The validity and reliability of the scale for the Turkish population were determined by İkiz and Yıldırım Usta (2016), and the Cronbach alpha coefficient of the scale was reported to be 0.91.
  arm group label: Video based education
  arm group type: Experimental
  description: The video was prepared by the researchers in line with the literature. Expert opinion was obtained from 10 individuals with at least a doctorate and studies on the subject of video content. In line with expert opinions, the video content was updated and finalized. Patient education with the prepared video was provided by one of the researchers involved in the study. The video education took 20 minutes in total.
  Topics: Video recordings on of fistula care was done by the researchers in the vocational skills laboratory. The video flow plan included the introduction of the materials to be used in fistula care as well as the researcher's presentation of how to manage the fistula. Fistula care steps were performed on the simulation model. In addition, the precautions to be taken during the application and what to do in case of possible complications were also shown.
  arm group label: Face to face education
  arm group type: Experimental
  description: The patients were trained on fistula care by the researcher. Fistula care training was given to the patients in the control group using face-to-face education technique. In this training, researcher verbally explained fistula care to patients. The training was conducted one-on-one with the patient in the patient's room and lasted 10 minutes. The training was presented to the patient through the lecture method. The training was also supported by the question-and-answer method. The training was given twice, one week apart, when patients came for hemodialysis treatment after the condition of the patients on dialysis stabilized.
  intervention type: Other
  intervention name: Video based education
  description: The video was prepared by the researchers in line with the literature. Expert opinion was obtained from 10 individuals with at least a doctorate and studies on the subject of video content. In line with expert opinions, the video content was updated and finalized. Patient education with the prepared video was provided by one of the researchers involved in the study. The video education took 20 minutes in total.
  arm group label: Video based education
  intervention type: Other
  intervention name: Face to face education
  description: The patients were trained on fistula care by the researcher. Fistula care training was given to the patients in the control group using face-to-face education technique. In this training, researcher verbally explained fistula care to patients. The training was conducted one-on-one with the patient in the patient's room and lasted 10 minutes. The training was presented to the patient through the lecture method. The training was also supported by the question-and-answer method. The training was given twice, one week apart, when patients came for hemodialysis treatment after the condition of the patients on dialysis stabilized.
  arm group label: Face to face education
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Izmir Bakircay University
  investigator full name: seda şahan
  investigator title: Izmir Bakircay University
  mesh term: Fistula
  mesh term: Hemolysis
  sharing ipd: No
  ipd description: Information can be obtained from the principal investigator via e-mail.