<?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>IRCT20231124060162N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-17</date_registration>
      <primary_sponsor>Baghdad University/ Collage of Nursing</primary_sponsor>
      <public_title>Effectiveness of an Instructional Program on Adherence to Hemodialysis and Associated Factors among Patients with End Stage Renal Failure</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of an Instructional Program on Adherence to Hemodialysis and Associated Factors among Patients with End Stage Renal Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>109</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74570</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: To achieve single blind in this research, a single blind randomized controlled trial conducted to evaluate the effectiveness of an instruction program on adherence to hemodialysis and associated factors among patients with end stage renal failure. By using simple randomization method by using two cards blue and red put in the box the blue card represented the intervention group, which received the instruction program, and the red card represented the control group, which received usual care. Then all participants were allowed to choose one of these cards. The participants were not aware of their group allocation, but the researchers were.</study_design>
      <phase>N/A</phase>
      <hc_freetext>end stage renal disease.</hc_freetext>
      <i_freetext>control group: patients in the control group received routine instruction provided by the nursing staff in the hemodialysis department as the same time as the intervention group. after that measuring adherence to hemodialysis by using ESRD-AQ.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data will be the results of ESRD-AQ that measure adherence to hemodialysis and associated factors among patients with end stage renal failure after applying instruction program for intervention group and compare the result with the control group

When:
once the process of data collection, analysis, and successful publishing of manuscript, all the related files will become available

To whom:
available for academic nursing and any researcher who is interested in the data

Conditions:
the data could be used after getting the permission via email. also, users need to acknowledge the owner

Where to obtain:
users can ask for the data and permission via email at tabarak.abd2202m@conursing.uobaghdad.edu.iq

How to obtain:
preparing a summary report of the research findings, highlighting the key outcomes, conclusions, and recommendations. This document will be shared electronically as a PDF file. The process to request access to this document involves: a. Request Submission: Interested individuals can submit a formal request for the research findings. b. Review and Approval: The requests will be reviewed to ensure they comply with ethical guidelines and any applicable data protection regulations. c. Access Provision: If approved, the research findings report will be shared electronically with the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tabarak Abdul Sahib Abdul Zahraa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Amara</address>
        <city>Al-Amara City</city>
        <country1>Iraq</country1>
        <zip>N/A</zip>
        <telephone>+964 771 243 4929</telephone>
        <email>tabarak.abd2202m@conursing.uobaghdad.edu.iq</email>
        <affiliation>Baghdad University/ Collage of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tabarak Abdul Sahib Abdul Zahraa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Amara</address>
        <city>Al-Amara City</city>
        <country1>Iraq</country1>
        <zip>N/A</zip>
        <telephone>+964 771 243 4929</telephone>
        <email>tabarak.abd2202m@conursing.uobaghdad.edu.iq</email>
        <affiliation>Baghdad University/ Collage of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with end stage renal failure 18 years old and above
undergoing hemodialysis
patients who are able write and read</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients who refuse to participate in the study
patients who  are unable to write and read
patients with mental state disorders</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control group: patients in the control group received routine instruction provided by the nursing staff in the hemodialysis department as the same time as the intervention group. after that measuring adherence to hemodialysis by using ESRD-AQ</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary outcome variable is adherence to hemodialysis. Timepoint: before intervention and 2 weeks after intervention. Method of measurement: End Stage Renal Disease Adherence Questionnaire ESRD-AQ.</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>the author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-22</approval_date>
        <contact_name>Ethics committee in Collage of Nursing at University of Baghdad</contact_name>
        <contact_address>Bab-Al-Muadhim Baghdad City Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
