<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210424051067N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of education on the quality of nutrition of patients undergoing hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education on the quality of nutrition of patients undergoing hemodialysis in the prevalence of COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55820</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A total of 60 patients with random entry blocking criteria with 4 blocks will be identified using a random number table of Random Allocation Software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. The sample allocation ratio will be 1: 1 and will be divided into intervention and control groups. Patients will then be instructed based on the blocks obtained and in the order of allocation sequence, Blinding description: This study is a one-way blind randomized clinical trial. In this way, patients are divided into two groups by one of the researchers who do not interfere in the intervention and evaluation of results. The intervention group is labeled A and the control group is labeled B. Using a table of random numbers, participants are randomly divided into groups A and B in blocks of four [ABAB, BAAB, etc. ]. The data analyst does not know in which group each participant was divided. Before dividing, all participants are told that dividing them into groups will not harm them, and they will be informed in order to be divided into groups. The experimental group receives educational intervention and the control group receives routine care and training.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic renal failure.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group in this study is a group of 30 people, all of whom will be emphasized to participate in the initial session with 10 hours of fasting per day with a family member who has the necessary knowledge about using the Internet. And take a blood sample of albumin and serum TIBC in the hemodialysis ward of Imam Khomeini Hospital in Jiroft. Before and after the intervention, blood samples will be taken for free and according to laboratory standards and their height and weight will be measured and body mass index will be calculated and recorded. The questionnaires are then completed by interview. Educational materials will be presented through cyberspace in the form of educational materials in the form of films, images, scientific texts, etc. in 10 sessions, as well as times for questions and answers and discussions. 3 months after the intervention, the data will be collected again by the same questionnaires. Intervention 2: Control group: The control group in this study is a group of 30 people who receive routine training and interventions according to the previous schedule.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdiyeh Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa St., Imam Khomeini Hospital</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>78611764787</zip>
        <telephone>+98 34 4331 6313</telephone>
        <email>rafiei.2001@yahoo.com</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Khandan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Kerman , Valiasr Blvd.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7635131167</zip>
        <telephone>+98 34 4331 1686</telephone>
        <email>mkhandan@iauk.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research
Have a minimum literacy rate
Smartphone access</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Creating unexpected conditions for the patient
Reluctance to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>End stage renal disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group in this study is a group of 30 people, all of whom will be emphasized to participate in the initial session with 10 hours of fasting per day with a family member who has the necessary knowledge about using the Internet. And take a blood sample of albumin and serum TIBC in the hemodialysis ward of Imam Khomeini Hospital in Jiroft. Before and after the intervention, blood samples will be taken for free and according to laboratory standards and their height and weight will be measured and body mass index will be calculated and recorded. The questionnaires are then completed by interview. Educational materials will be presented through cyberspace in the form of educational materials in the form of films, images, scientific texts, etc. in 10 sessions, as well as times for questions and answers and discussions. 3 months after the intervention, the data will be collected again by the same questionnaires.</i_keyword>
      <i_keyword>Control group: The control group in this study is a group of 30 people who receive routine training and interventions according to the previous schedule.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of nutrition. Timepoint: Before the intervention and three months after. Method of measurement: questionnaire - Blood test (TIBC-Alb).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-12</approval_date>
        <contact_name>Ethics committee of Azad University of Kerman</contact_name>
        <contact_address>Azad University of Kerman, Valiasr Blv., Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
