<?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>IRCT20220521054937N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-05</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of infographic and pamphlets on hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of infographic and pamphlet on laboratory indices and weight in patients under hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>234</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63732</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research, patients will be selected by census method and will be assigned to three groups (infographic, pamphlet, control) in a block random manner.Before block randomization, the letter A will be assigned to the Infographic group, the letter B will be assigned to the pamphlet group, and the letter C will be assigned to the control group And in this way, after the randomization, the names of the patients will be written in alphabetical order, and in the opposite column, the letters B, A, and C will be randomly placed in front of the names of each patient.In the block randomization method, each person has an equal chance to be placed in each of the three groups. (Although in this study, all patients will participate in a census, however, for more certainty, according to the analysis of the respected professor of statistics, 40 people will be included in each group), Blinding description: In each shift, in coordination with the patients and the head of the center, in order to prevent information leakage during the presentation of educational content between patients in different groups, the infographic group will be placed in the first floor, the pamphlet group will be placed on the ground floor, and the control group will be placed on the basement floor.In order to prevent the leakage of information between different groups, as much as possible, groups that are related by family will be in separate groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this group, topics such as: tips to prevent thirst, side effects of increasing fluids in the body, the role of potassium, phosphorus, sodium and calcium in the body and the side effects of increasing and decreasing them on the body, solutions to improve the amount of phosphorus and sodium and Calcium and potassium in the body are presented to patients in the form of infographic. Intervention 2: Intervention group 2: In this group, topics such as: tips to prevent thirst, side effects of increasing fluids in the body, the role of potassium, phosphorus, sodium and calcium in the body and the side effects of increasing and decreasing them on the body, solutions to improve the amount of phosphorus and sodium, calcium and potassium It is presented to patients in the form of pamphlets. Intervention 3: Control group: During this period, the samples of the control group will receive routine care as before and will not receive training from the researcher.</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 No any detail in this way.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zakieh Aliyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hedayat 6, Moalem town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3818759335</zip>
        <telephone>+98 86 3369 0389</telephone>
        <email>it@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zakiah Aliyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hedayat 6, Moalem town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176341</zip>
        <telephone>+98 86 3369 0389</telephone>
        <email>it@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Ability to communicate verbally
Willingness to cooperate in the study
Perform at least two dialysis sessions per week
Have at least 3 months of dialysis history
lack of participation other nutrition-related training classes in the past year
Ability to read</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Vision and hearing problems
Long-term referral to other medical centers in order to follow up and continue the treatment process</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In this group, topics such as: tips to prevent thirst, side effects of increasing fluids in the body, the role of potassium, phosphorus, sodium and calcium in the body and the side effects of increasing and decreasing them on the body, solutions to improve the amount of phosphorus and sodium and Calcium and potassium in the body are presented to patients in the form of infographic.</i_keyword>
      <i_keyword>Intervention group 2: In this group, topics such as: tips to prevent thirst, side effects of increasing fluids in the body, the role of potassium, phosphorus, sodium and calcium in the body and the side effects of increasing and decreasing them on the body, solutions to improve the amount of phosphorus and sodium, calcium and potassium It is presented to patients in the form of pamphlets.</i_keyword>
      <i_keyword>Control group: During this period, the samples of the control group will receive routine care as before and will not receive training from the researcher</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of laboratory indicators calcium. Timepoint: Before the study, 2 weeks after the start of the intervention and 6 weeks after the intervention. Method of measurement: Calcium measurement using blood sampling.</prim_outcome>
      <prim_outcome>The amount of phosphorus laboratory index. Timepoint: Before the study, 2 weeks after the start of the intervention and 6 weeks after the intervention. Method of measurement: Phosphorus measurement using blood sampling.</prim_outcome>
      <prim_outcome>The amount of sodium laboratory index. Timepoint: Before the study, 2 weeks after the start of the intervention and 6 weeks after the intervention. Method of measurement: Sodium measurement using blood sampling.</prim_outcome>
      <prim_outcome>The amount of potassium laboratory index. Timepoint: Before the study, 2 weeks after the start of the intervention and 6 weeks after the intervention. Method of measurement: Potassium measurement using blood sampling.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before the study, 2 weeks after the start of the intervention and 6 weeks after the intervention. Method of measurement: Weight measurement using a standard scale.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-01</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research, Arak University of Medical Sciences, Basij Square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
